Shunting systems with rotation-based flow control assemblies, and associated systems and methods

ABSTRACT

The present technology relates to intraocular shunting systems and methods. In some embodiments, the present technology includes intraocular shunting systems that include a drainage element having an inflow portion configured for placement within an anterior chamber of the eye outside of an optical field of view of the patient and an outflow portion configured for placement at a different location of the eye. The system can also include a flow control assembly having a rotational control element operably coupled to the drainage element. The flow control assembly can further include an actuation structure coupled to the rotational control element and configured to selectively change an orientation of the rotational control element. An amount of fluid through the inflow portion and/or the outflow portion can vary based on the selected orientation of the rotational control element.

CROSS-REFERENCE TO RELATED APPLICATION(S)

The present application is a continuation of U.S. patent applicationSer. No. 17/175,332, filed Feb. 12, 2021, which claims priority to thefollowing provisional applications:

U.S. Provisional Patent Application No. 62/976,890, filed Feb. 14, 2020;

U.S. Provisional Patent Application No. 62/981,411, filed Feb. 25, 2020;

U.S. Provisional Patent Application No. 63/116,674, filed Nov. 20, 2020;and

U.S. Provisional Patent Application No. 63/140,543, filed Jan. 22, 2021.

All of the foregoing applications are incorporated herein by referencein their entireties. Further, components and features of embodimentsdisclosed in the applications incorporated by reference may be combinedwith various components and features disclosed and claimed in thepresent application.

TECHNICAL FIELD

The present technology generally relates to implantable medical devicesand, in particular, to intraocular shunting systems and associatedmethods for selectively controlling fluid flow between differentportions of a patient's eye.

BACKGROUND

Glaucoma is a degenerative ocular condition involving damage to theoptic nerve that can cause progressive and irreversible vision loss.Glaucoma is frequently associated with ocular hypertension, an increasein pressure within the eye resultant from an increase in production ofaqueous humor (“aqueous”) within the eye and/or a decrease in the rateof outflow of aqueous from within the eye into the blood stream. Aqueousis produced in the ciliary body at the boundary of the posterior andanterior chambers of the eye. It flows into the anterior chamber andeventually into the capillary bed in the sclera of the eye. Glaucoma istypically caused by a failure in mechanisms that transport aqueous outof the eye and into the blood stream.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present technology can be better understood withreference to the following drawings. The components in the drawings arenot necessarily drawn to scale. Instead, emphasis is placed onillustrating clearly the principles of the present technology.Furthermore, components can be shown as transparent in certain views forclarity of illustration only and not to indicate that the component isnecessarily transparent. Components may also be shown schematically.

FIG. 1A is a simplified front view of an eye with an implanted shuntconfigured in accordance with an embodiment of the present technology.

FIG. 1B is an isometric view of the eye and implanted shunt of FIG. 1A.

FIG. 2 is a front view of a flow control assembly of an intraocularshunting system configured in accordance with an embodiment of thepresent technology.

FIG. 3 is a front view of a flow control assembly of an intraocularshunting system configured in accordance with another embodiment of thepresent technology.

FIG. 4A is a front view of a flow control assembly of an intraocularshunting system configured in accordance with a further embodiment ofthe present technology.

FIG. 4B is a front view of a first plate member of the assembly of FIG.4A.

FIG. 4C is a front view of a second plate member positioned within thefirst plate member of the assembly of FIG. 4A.

FIG. 5A is a top view of a flow control assembly of an intraocularshunting system configured in accordance with a further embodiment ofthe present technology.

FIG. 5B is a side cross-sectional view of the assembly of FIG. 5A.

FIG. 6A is a flow control assembly of an intraocular shunting systemconfigured in accordance with another embodiment of the presenttechnology.

FIG. 6B is a front view of the assembly of FIG. 6A in a loaded and/orcompressed configuration.

FIG. 6C is a front view of the assembly of FIG. 6B in a rotatedconfiguration.

FIG. 7A is a front view of an intraocular shunting system configured inaccordance with select embodiments of the present technology.

FIG. 7B is an enlarged view of a flow control assembly of theintraocular shunting system shown in FIG. 7A.

FIG. 7C is an enlarged view of a portion of the flow control assemblyshown in FIG. 7B.

FIG. 7D is an enlarged view of an actuation assembly of the intraocularshunting system of FIG. 7A in a first configuration.

FIG. 7E is an enlarged front view of the actuation assembly of FIG. 7Din a second configuration.

FIG. 8A is a front view of another intraocular shunting systemconfigured in accordance with select embodiments of the presenttechnology.

FIG. 8B is a side view of the intraocular shunting system of FIG. 8A.

FIG. 8C is an enlarged front view of a flow control assembly of theintraocular shunting system of FIG. 8A.

FIGS. 9A-9D illustrate an actuator for selectively controlling the flowof fluid through shunting systems and configured in accordance withselect embodiments of the present technology.

FIGS. 10A-10D illustrate another actuator for selectively controllingthe flow of fluid through shunting systems and configured in accordancewith select embodiments of the present technology.

FIGS. 11A-11D illustrate yet another actuator for selectivelycontrolling the flow of fluid through shunting systems and configured inaccordance with select embodiments of the present technology.

FIGS. 12A-12D illustrate yet another actuator for selectivelycontrolling the flow of fluid through shunting systems and configured inaccordance with select embodiments of the present technology.

FIGS. 13A-13D illustrate yet another actuator for selectivelycontrolling the flow of fluid through shunting systems and configured inaccordance with select embodiments of the present technology.

FIGS. 14A-14E illustrate a flow control assembly for selectivelycontrolling the flow of fluid through shunting systems and configured inaccordance with select embodiments of the present technology.

FIGS. 15A-15D illustrate another flow control assembly for selectivelycontrolling the flow of fluid through shunting systems and configured inaccordance with select embodiments of the present technology.

FIG. 16 is a flowchart of a method for manufacturing an adjustableintraocular shunting system in accordance with embodiments of thepresent technology.

FIG. 17 is a flowchart of a method for treating a patient havingglaucoma using an adjustable intraocular shunting system configured inaccordance with embodiments of the present technology.

DETAILED DESCRIPTION

The present technology is generally directed to shunting systems forselectively controlling the flow of fluid between a first body region ofa patient, such as an anterior chamber of the patient's eye, and asecond body region of the patient, such as a bleb space. The shuntingsystems disclosed herein can include a drainage element having a channelextending therethrough for transporting fluid from the first body regionto the second body region. The shunting systems can also include a flowcontrol assembly or actuator having a control element rotatably moveablerelative to the drainage element, and at least one shape memoryactuation element that, when actuated, pivots or otherwise rotates thecontrol element relative to the drainage element. Pivoting/rotating thecontrol element can change the fluid resistance through one or moreapertures (e.g., fluid inlets) in fluid communication with the channel,thereby changing the drainage rate through the drainage element. Asdescribed in detail below, use of a rotational motion to control theflow of fluid through a shunting system is expected to provide severaladvantages over flow control elements that rely on linear motion.

The terminology used in the description presented below is intended tobe interpreted in its broadest reasonable manner, even though it isbeing used in conjunction with a detailed description of certainspecific embodiments of the present technology. Certain terms may evenbe emphasized below; however, any terminology intended to be interpretedin any restricted manner will be overtly and specifically defined assuch in this Detailed Description section. Additionally, the presenttechnology can include other embodiments that are within the scope ofthe examples but are not described in detail with respect to FIGS. 1-17.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment of the present technology. Thus, theappearances of the phrases “in one embodiment” or “in an embodiment” invarious places throughout this specification are not necessarily allreferring to the same embodiment. Furthermore, the particular featuresor characteristics may be combined in any suitable manner in one or moreembodiments.

Reference throughout this specification to relative terms such as, forexample, “generally,” “approximately,” and “about” are used herein tomean the stated value plus or minus 10%. Reference throughout thisspecification to the term “resistance” refers to fluid resistance unlessthe context clearly dictates otherwise. The terms “drainage rate,” “flowrate,” and “flow” are used interchangeably to describe the movement offluid through a structure.

Although certain embodiments herein are described in terms of shuntingfluid from an anterior chamber of an eye, one of skill in the art willappreciate that the present technology can be readily adapted to shuntfluid from and/or between other portions of the eye, or, more generally,from and/or between a first body region and a second body region.Moreover, while the certain embodiments herein are described in thecontext of glaucoma treatment, any of the embodiments herein, includingthose referred to as “glaucoma shunts” or “glaucoma devices” maynevertheless be used and/or modified to treat other diseases orconditions, including other diseases or conditions of the eye or otherbody regions. For example, the systems described herein can be used totreat diseases characterized by increased pressure and/or fluidbuild-up, including but not limited to heart failure (e.g., heartfailure with preserved ejection fraction, heart failure with reducedejection fraction, etc.), pulmonary failure, renal failure,hydrocephalus, and the like. Moreover, while generally described interms of shunting aqueous, the systems described herein may be appliedequally to shunting other fluid, such as blood or cerebrospinal fluid,between the first body region and the second body region.

The headings provided herein are for convenience only and do notinterpret the scope or meaning of the claimed present technology.

A. Intraocular Shunts for Glaucoma Treatment

Glaucoma refers to a group of eye diseases associated with damage to theoptic nerve which eventually results in vision loss and blindness. Asnoted above, glaucoma is a degenerative ocular condition characterizedby an increase in pressure within the eye resulting from an increase inproduction of aqueous within the eye and/or a decrease in the rate ofoutflow of aqueous from within the eye into the blood stream. Theincreased pressure leads to injury of the optic nerve over time.Unfortunately, patients often do not present with symptoms of increasedintraocular pressure until the onset of glaucoma. As such, patientstypically must be closely monitored once increased pressure isidentified even if they are not symptomatic. The monitoring continuesover the course of the disease so clinicians can intervene early to stemprogression of the disease. Monitoring pressure requires patients tovisit a clinic site on a regular basis which is expensive,time-consuming, and inconvenient. The early stages of glaucoma aretypically treated with drugs (e.g., eye drops) and/or laser therapy.When drug/laser treatments no longer suffice, however, surgicalapproaches can be used. Surgical or minimally invasive approachesprimarily attempt to increase the outflow of aqueous from the anteriorchamber to the blood stream either by the creation of alternative fluidpaths or the augmentation of the natural paths for aqueous outflow.

FIGS. 1A and 1B illustrate a human eye E and suitable location(s) inwhich a shunt may be implanted within the eye E in accordance withembodiments of the present technology. More specifically, FIG. 1A is asimplified front view of the eye E with an implanted shunt 100, and FIG.1B is an isometric view of the eye E and the shunt 100 of FIG. 1A.Referring first to FIG. 1A, the eye E includes a number of muscles tocontrol its movement, including a superior rectus SR, inferior rectusIR, lateral rectus LR, medial rectus MR, superior oblique SO, andinferior oblique 10. The eye E also includes an iris, pupil, and limbus.

Referring to FIGS. 1A and 1B together, the shunt 100 can have a drainageelement 105 (e.g., a drainage tube) positioned such that an inflowportion 101 is positioned in an anterior chamber of the eye E, and anoutflow portion 102 is positioned at a different location within the eyeE, such as a bleb space. The shunt 100 can be implanted in a variety oforientations. For example, when implanted, the drainage element 105 mayextend in a superior, inferior, medial, and/or lateral direction fromthe anterior chamber. Depending upon the design of the shunt 100, theoutflow portion 102 can be placed in a number of different suitableoutflow locations (e.g., between the choroid and the sclera, between theconjunctiva and the sclera, etc.).

Outflow resistance can change over time for a variety of reasons, e.g.,as the outflow location goes through its healing process after surgicalimplantation of a shunt (e.g., shunt 100) or further blockage in thedrainage network from the anterior chamber through the trabecularmeshwork, Schlemm's canal, the collector channels, and eventually intothe vein and the body's circulatory system. Accordingly, a clinician maydesire to modify the shunt after implantation to either increase ordecrease the outflow resistance in response to such changes or for otherclinical reasons. For example, in many procedures the shunt is modifiedat implantation to temporarily increase its outflow resistance. After aperiod of time deemed sufficient to allow for healing of the tissues andstabilization of the outflow resistance, the modification to the shuntis reversed, thereby decreasing the outflow resistance. In anotherexample, the clinician may implant the shunt and after subsequentmonitoring of intraocular pressure determine a modification of thedrainage rate through the shunt is desired. Such modifications can beinvasive, time-consuming, and/or expensive for patients. If such aprocedure is not followed, however, there is a high likelihood ofcreating hypotony (excessively low eye pressure), which can result infurther complications, including damage to the optic nerve. In contrast,intraocular shunting systems configured in accordance with embodimentsof the present technology allow the clinician to selectively adjust theflow of fluid through the shunt after implantation without additionalinvasive surgical procedures.

The shunts described herein can be implanted having a first drainagerate and subsequently remotely adjusted to achieve a second, differentdrainage rate. The adjustment can be based on the needs of theindividual patient. For example, the shunt may be implanted at a firstlower flow rate and subsequently adjusted to a second higher flow rateas clinically necessary. The shunts described herein can be deliveredusing either ab interno or ab externo implant techniques, and can bedelivered via needles. The needles can have a variety of shapes andconfigurations to accommodate the various shapes of the shunts describedherein. Details of the implant procedure, the implant devices, and blebformation are described in greater detail in International PatentApplication No. PCT/US20/41152, the disclosure of which is incorporatedby reference herein for all purposes.

In many of the embodiments described herein, the flow control assembliesare configured to introduce features that selectively impede orattenuate fluid flow through the shunt during operation. In this way,the flow control assemblies can incrementally or continuously change theflow resistance through the shunt to selectively regulate pressureand/or flow. The flow control assemblies configured in accordance withthe present technology can accordingly adjust the level of interferenceor compression between a number of different positions, and accommodatea multitude of variables (e.g., IOP, aqueous production rate, nativeaqueous outflow resistance, and/or native aqueous outflow rate) toprecisely regulate flow rate through the shunt.

The disclosed flow control assemblies can be operated using energy. Thisfeature allows such devices to be implanted in the patient and thenmodified/adjusted over time without further invasive surgeries orprocedures for the patient. Further, because the devices disclosedherein may be actuated via energy from an external energy source (e.g.,a laser), such devices do not require any additional power to maintain adesired orientation or position. Rather, the actuators/fluid resistorsdisclosed herein can maintain a desired position/orientation withoutpower. This can significantly increase the usable lifetime of suchdevices and enable such devices to be effective long after the initialimplantation procedure.

B. Operation of Actuation Elements

Some embodiments of the present technology include actuation assemblies(e.g., flow control assemblies, flow control mechanisms, etc.) that haveat least one actuation element coupled to a moveable control element(e.g., an arm, a gating element, a projection, etc.). As described indetail below, the moveable control element can be configured tointerface with (e.g., at least partially block) a corresponding port oraperture. The port can be an inflow port or an outflow port. Movement ofthe actuation element(s) generates (e.g., translational and/orrotational) movement of the moveable element.

The actuation element(s) can include a shape memory material (e.g., ashape memory alloy, or a shape memory polymer). Movement of theactuation element(s) can be generated through applied stress and/or useof a shape memory effect (e.g., as driven by a change in temperature).The shape memory effect enables deformations that have altered anelement from its preferred geometric configuration (e.g., original orfabricated configuration, shape-set configuration, heat-setconfiguration, etc.) to be largely or entirely reversed during operationof the flow control assembly. For example, thermal actuation (heating)can reverse deformation(s) by inducing a change in state (e.g., phasechange) in the actuator material, inducing a temporary elevated internalstress that promotes a shape change toward the preferred geometricconfiguration. For a shape memory alloy, the change in state can be froma martensitic phase (alternatively, R-phase) to an austenitic phase. Fora shape memory polymer, the change in state can be via a glasstransition temperature or a melting temperature. The change in state canreverse deformation(s) of the material—for example, deformation withrespect to its preferred geometric configuration—without any (e.g.,externally) applied stress to the actuation element. That is, adeformation that is present in the material at a first temperature(e.g., body temperature) can be (e.g., thermally) recovered and/oraltered by raising the material to a second (e.g., higher) temperature.Upon cooling (and changing state, e.g., back to martensitic phase), theactuation element retains its preferred geometric configuration. Withthe material in this relatively cooler-temperature condition it mayrequire a lower force or stress to thermoelastically deform thematerial, and any subsequently applied external stress can cause theactuation element to once again deform away from the original geometricconfiguration.

The actuation element(s) can be processed such that a transitiontemperature at which the change in state occurs (e.g., the austenitestart temperature, the austenite final temperature, etc.) is above athreshold temperature (e.g., body temperature). For example, thetransition temperature can be set to be about 45 deg. C., about 50 deg.C., about 55 deg. C., or about 60 deg. C. In some embodiments, theactuator material is heated from body temperature to a temperature abovethe austenite start temperature (or alternatively above the R-phasestart temperature) such that an upper plateau stress (e.g., “UPS_bodytemperature”) of the material in a first state (e.g., thermoelasticmartensitic phase, or thermoelastic R-phase at body temperature) islower than an upper plateau stress (e.g., “UPS_actuated temperature”) ofthe material in a heated state (e.g., superelastic state), whichachieves partial or full free recovery. For example, the actuatormaterial can be heated such that UPS_actuated temperature>UPS_bodytemperature. In some embodiments, the actuator material is heated frombody temperature to a temperature above the austenite start temperature(or alternatively above the R-phase start temperature) such that anupper plateau stress of the material in a first state (e.g.,thermoelastic martensite or thermoelastic R-phase at body temperature)is lower than a lower plateau stress (e.g., “LPS”) of the material in aheated state (e.g., superelastic state), which achieves partial or fullfree recovery. For example, the actuator material can be aged such thatLPS_activated temperature>UPS_body temperature. In some embodiments, theactuator material is heated from body temperature to a temperature abovethe austenite start temperature (or alternatively above the R-phasestart temperature) such that an upper plateau stress of the material ina first state (e.g., thermoelastic martensite or thermoelastic R-phase)is higher than a lower plateau stress of the material in a heated state,which achieves partial free recovery. For example, the actuator materialcan be aged such that LPS_activated temperature<UPS_body temperature.

The flow control assembly can be formed such that the actuation elementshave substantially the same preferred geometric configuration (e.g.,memory shape, or length, L0). The flow control assembly can be assembledsuch that, upon introduction into a patient (e.g., implantation), atleast one (e.g., a first) actuation element/shape memory element hasbeen deformed with respect to its preferred geometric configuration(e.g., to have L1≠L0), while at least one other opposing (e.g., asecond) actuation element/shape memory element positioned adjacent tothe first actuation element is substantially at its preferred geometricconfiguration (e.g., L0). In other embodiments, however, both the firstand second actuation elements may be deformed with respect to theircorresponding preferred geometric configuration upon introduction intothe patient (e.g., the first actuation element is contracted relative toits preferred geometric configuration and the second actuation elementis expanded relative to its preferred geometric configuration).

In some embodiments of the present technology, L1>L0—for example, thedeformed first actuation element is elongated with respect to itspreferred “shape memory” length. In some embodiments, L1<L0—for example,the deformed first actuation element is compressed with respect to itspreferred shape memory length. The flow control assembly can be formedsuch that, in operation, its overall dimension (e.g., overall length) issubstantially fixed (e.g., L0+L1=a constant). For example, (e.g.,outermost) ends of the actuation elements can be fixed, such thatmovement of the actuation elements occurs between the points offixation. The overall geometry of the actuation elements, along with thelengths, can be selected such that, in operation, deformation within theactuation elements remains below about 10%, about 9%, about 8%, about7%, or about 6%.

The (e.g., first and second) actuation elements are arranged such that amovement (e.g., deflection or deformation) of the first actuationelement/first shape memory element is accompanied by (e.g., causes) anopposing movement of the second actuation element/second shape memoryelement. The movement can be a deflection or a deformation. Inoperation, selective heating of the first actuation element of the flowcontrol assembly causes it to move to and/or toward its preferredgeometric configuration (e.g., revert from L1 to L0), moving the coupledmoveable element. At the same time, the elongation of the firstactuation element is accompanied by (e.g., causes) a compression of thesecond actuation element (e.g., from L0 to L1). The second actuationelement is not heated (e.g., remains at body temperature), and thereforethe second actuation element deforms (e.g., remains martensitic andcompresses). The first actuation element cools following heating, andreturns to a state in which it can be plastically deformed. To reversethe configuration of the flow control assembly (e.g., the position ofthe moveable element), the second actuation element is heated to move toand/or toward its preferred geometric configuration (e.g., from L1 toL0). The return of the second actuation element to its preferredgeometric configuration causes the moveable element to move back to itsprior position, and compresses the first actuation element (e.g., fromL0 to L1). The position of the moveable element for the flow controlassembly can be repeatably toggled (e.g., between open and closed) byrepeating the foregoing operations. The heating of an actuation elementcan be accomplished via application of incident energy (e.g., via alaser or inductive coupling). Further, as mentioned above, the source ofthe incident energy may be external to the patient (e.g., non-invasive).

C. Flow Control Assemblies for Intraocular Shunting Systems

As provided above, the present technology is generally directed tointraocular shunting systems. Such systems include a drainage element(e.g., an elongated flow tube or plate) configured to shunt fluid awayfrom the anterior chamber of the eye. For example, the drainage elementcan include an inflow portion configured for placement within theanterior chamber (e.g., at a location away from the optical field ofview) and an outflow portion configured for placement at a differentlocation of the eye (e.g., at a subconjunctival bleb space). Toselectively control fluid flow through the drainage element (e.g.,post-implantation), the system can further include a flow controlassembly operably coupled to the drainage element. In some embodiments,the flow control assembly includes a rotational control element operablycoupled to a portion of the drainage element (e.g., to the outflow or tothe inflow portion). The rotational control element can be or include acam, plate, lever, gate valve, or any other structure capable ofrotating to a plurality of different orientations. The orientation ofthe rotational control element or a component thereof can affect theamount of fluid flow through the portion of the drainage element.

FIG. 2 is a front view of a flow control assembly 200 of an intraocularshunting system configured in accordance with an embodiment of thepresent technology. The flow control assembly 200 includes a rotationalcontrol element 202 coupled to an actuation structure 204. Therotational control element 202 can include an elongated member 205having a first end portion 206 a, a second end portion 206 b, and a camportion 206 c disposed between the first and second end portions 206a-b. The elongated member 205 can be configured to rotate about arotational axis A₁ (e.g., in a clockwise and/or counterclockwisedirection). In some embodiments, the cam portion 206 c includes anaperture 208 configured to receive a fastener (e.g., a pin, screw,pivot, etc.—not shown) allowing for rotation of the elongated member 205about the rotational axis A₁.

The rotational control element 202 can be operably coupled to an outflowportion of a drainage element (not shown) to selectively control fluidflow therethrough (e.g., to modulate pressure within the anteriorchamber of the eye). For example, the outflow portion can include one ormore apertures formed therein to permit fluid outflow (e.g., similar tothe outflow ports 102 described with respect to FIGS. 1A and 1B). Therotational control element 202 can be positioned near or adjacent to theaperture(s) such that, depending on the orientation of the rotationalcontrol element 202, one or more apertures can be obstructed orunobstructed by the rotational control element 202. When rotated to afirst orientation, the rotational control element 202 can partially orcompletely cover the aperture(s) to partially or completely obstructfluid flow therefrom. When rotated to a second orientation, therotational control element 202 can be spaced away from the aperture(s)such that the aperture(s) are accessible and fluid can flow therefromwith little or no obstruction. As a result, the amount of fluid flowthrough the outflow portion can vary based on the number of obstructedaperture(s) and/or the extent to which each aperture is obstructed. Inother embodiments, the rotational control element 202 is coupled to aninflow portion of a drainage element (not shown) such that one or moreinflow apertures (not shown) can be unobstructed or partially to fullyobstructed or unobstructed by the rotational control element 202.

In the illustrated embodiment, for example, the elongated member 205 ora component thereof (e.g., the cam portion 206 c, the first end portion206 a, and/or the second end portion 206 b) can be positioned near oradjacent to the aperture(s) of an outflow portion of a drainage element(not shown). When the elongated member 205 is rotated to a firstorientation, the cam portion 206 c can partially or completely cover theaperture(s). In some embodiments, when the elongated member 205 isrotated to a second orientation, a notch 209 formed in the cam portion206 c can be positioned over the aperture(s) such that the cam portion206 c is spaced apart from the aperture(s) and no longer obstructs fluidflow therethrough.

The actuation structure 204 can be configured to implement rotation ofthe rotational control element 202. In the illustrated embodiment, forexample, the actuation structure 204 includes a first actuation element208 a and a second actuation element 208 b coupled to the rotationalcontrol element 202 (e.g., to elongated member 205). The first andsecond actuation elements 208 a-b can each be carried by a base support210 and can extend longitudinally between the base support 210 and therotational control element 202. For example, the first actuation element208 a can include a first end portion 212 a coupled to the base support210 and a second end portion 212 b coupled to the first end portion 206a of the elongated member 205. The second actuation element 208 b caninclude a first end portion 214 a coupled to the base support 210 and asecond end portion 214 b coupled to the second end portion 206 b of theelongated member 205.

In some embodiments, the first and second actuation elements 208 a-binclude one or more shape memory materials configured to at leastpartially transition from a first phase/state (e.g., a martensitic orintermediate state) to a second phase/state (e.g., an intermediate oraustenitic state) upon application of energy, as previously described.The first and second actuation elements 208 a-b can each be configuredto change in shape or otherwise transform between a first configuration(e.g., a memory shape, a preferred geometry, etc.) and a secondconfiguration (e.g., a shape different from the memory shape, a deformedgeometry, etc.) via a shape memory effect (e.g., when heated). Forexample, in some embodiments, the memory shape is a lengthenedconfiguration, while in other embodiments the memory shape is ashortened configuration.

In the illustrated embodiment, the first actuation element 208 a can beconfigured to transform to a lengthened configuration when heated torotatably move the rotational control element 202 along a firstdirection (e.g., counterclockwise), and the second actuation element 208b can be configured to transform to a lengthened configuration whenheated to rotatably move the rotational control element 202 along asecond, opposite direction (e.g., clockwise). In other embodiments, thefirst actuation element 208 a can be configured to transform to ashortened configuration when heated to rotatably move the rotationalcontrol element 202 along a first direction (e.g., clockwise), and thesecond actuation element 208 b can be configured to transform to ashortened configuration when heated to rotatably move the rotationalcontrol element 202 along a second, opposite direction (e.g.,counterclockwise). Optionally, the first and second actuation elements208 a-b can be configured to oppose each other, such that actuation ofone actuation element via the shape memory effect produces acorresponding deflection and/or deformation in the other actuationelement. For example, transformation of one actuation element into alengthened configuration can cause the other actuation element totransform into a shortened configuration, and/or transformation of oneactuation element into a shortened configuration can cause the otheractuation element to transform into a lengthened configuration.

The geometry of the first and second actuation element 208 a-b can beconfigured in a number of different ways. For example, in theillustrated embodiment, the first and second actuation elements 208 a-beach include a plurality of apices or bend regions 216 and a pluralityof struts 218 interconnected with each other to form a serpentine or“zig-zag”-shaped structure (reference numbers are shown only for theapices and struts of the first actuation element 208 a merely forpurposes of clarity). The first and second actuation elements 208 a-bcan each be transformed to the lengthened configuration by moving theapices 216 and/or struts 218 further away from each other (e.g., along alongitudinal direction). Conversely, the first and section actuationelements 208 a-b can each be transformed to the shortened configurationby moving the apices 216 and/or struts 218 closer to each other (e.g.,along a longitudinal direction).

In some embodiments, the first and second actuation elements 208 a-b areeach individually actuated by applying a stimulus to the entireactuation element. In other embodiments the stimulus can be applied toonly a portion of the actuation element. For example, a stimulus can beapplied to a plurality of different locations, such as to one or moreapices 216 and/or to one or more struts 218 of the selected actuationelement(s). In such embodiments, the stimulus can be applied to each ofthe different locations simultaneously or can be applied to differentlocations at different times (e.g., sequentially). As a result, theextent of the shape change can be modulated based on the number oflocations at which the stimulus is applied. For example, applying astimulus to a greater number of locations can produce a greater shapechange, while applying a stimulus to a fewer number of locations canproduce a smaller shape change.

It will be appreciated that the first and second actuation elements 208a-b can be configured in a number of different ways to allow forrotation-based actuation of the rotational control element 202. Forexample, although FIG. 2 illustrates the first and second actuationelements 208 a-b as each having four apices 216 and three struts 218, inother embodiments the first and second actuation elements 208 a-b caninclude a different number of apices (e.g., one, two, three, five, ormore) and/or a different number of struts (e.g., one, two, four, five,or more). Additionally, although FIG. 2 illustrates the apices 216 asbeing curved and the struts 218 as being linear, in other embodimentsthe apices 216 and/or struts 218 can have other geometries (e.g.,curved, linear, curvilinear, angular, etc.).

FIG. 3 is a front view of a flow control assembly 300 of an intraocularshunting system configured in accordance with another embodiment of thepresent technology. The flow control assembly 300 can be generallysimilar to the flow control assembly 200 described with respect to FIG.2 such that like reference numbers (e.g., rotational control element 202versus rotational control element 302) are used to identify similar oridentical components. Accordingly, discussion of the flow controlassembly 300 of FIG. 3 will be limited to those features that differfrom the flow control assembly 200 of FIG. 2 .

The flow control assembly 300 includes a rotational control element 302having an elongated member 305 with a first end portion 306 a, a secondend portion 306 b, and a cam portion 306 c therebetween. The first andsecond end portions 306 a-b can each include a respective retentionfeature (e.g., first retention feature 320 a and second retentionfeature 320 b) formed therein. The flow control assembly 300 furtherincludes an actuation structure 304 having a first actuation element 308a and a second actuation element 308 b. The first actuation element 308a can include a first end portion 312 a coupled to the base support 310and a second end portion 312 b engaged with the first retention feature320 a. The second actuation element 308 b can include a first endportion 314 a coupled to the base support 310 and a second end portion314 b engaged with the second retention feature 320 b. In someembodiments, the first and second retention features 320 a-b eachinclude a channel formed therein, and the second end portions 312 b, 314b are each shaped to be received within the corresponding channel. Thefirst and second retention features 320 a-b can be sized larger than therespective second end portions 312 b, 314 b to permit the second endportions 312 b, 314 b to move therewithin. As the first and secondactuation elements 308 a-b change in shape (e.g., via the shape memoryeffect as described herein), the first and second end portions 312 b,314 b can slide within their respective channels to rotatably move therotational control element 302.

FIGS. 4A-4C illustrate a flow control assembly 400 of an intraocularshunting system configured in accordance with a further embodiment ofthe present technology. More specifically, FIG. 4A is a front view ofthe assembly 400, FIG. 4B is a front view of a first plate member 420 ofthe assembly 400, and FIG. 4C is a front view of a second plate member430 of the assembly 400 positioned within the first plate member 420.

Referring first to FIG. 4A, the flow control assembly 400 includes arotational control element 402 coupled to an actuation structure 404.The rotational control element 402 can include an elongate member 405configured to rotate to a plurality of different orientations (e.g.,about a rotational axis A₂). The actuation structure 404 can include afirst actuation element 408 a and a second actuation element 408 bcoupled to the elongate member 405 and carried by a base support 410.The actuation structure 404 and elongate member 405 can be identical orgenerally similar to the corresponding components previously describedwith respect to FIGS. 2 and 3 . Accordingly, discussion of the flowcontrol assembly 400 of FIG. 4 will be limited to those features thatdiffer from the embodiments of FIGS. 2 and 3 .

Referring to FIGS. 4A-4C together, the rotational control element 402further includes a first plate member 420 and second plate member 430configured to rotatably move relative to the first plate member 420. Asbest seen in FIG. 4B, the first plate member 420 can have a generallyflattened shape and can include a flow inlet 422, a flow outlet 424, anda recessed portion 426 between the flow inlet 422 and the flow outlet424. The flow inlet 422 and flow outlet 424 can each include one or moreapertures, openings, ports, channels, etc. formed in a peripheralportion 428 of the first plate member 420 surrounding the recessedportion 426. The flow inlet 422 can be fluidly coupled to an outflowand/or inflow portion of a drainage element (e.g., for shunting fluidfrom the anterior chamber of the eye—not shown). The flow outlet 424 canbe fluidly coupled to a location in the eye (e.g., a subconjunctivalbleb space).

As best seen in FIG. 4C, the second plate member 430 can have agenerally flattened shape and can be positioned within the recessedportion 426 of the first plate member 420. The positioning of the secondplate member 430 within the recessed portion 426 can define a flowchannel 432 fluidly coupling the flow inlet 422 and the flow outlet 424.For example, in the illustrated embodiment, the second plate member 430is shaped similarly to the recessed portion 426 but has a smaller size(e.g., smaller surface area) such that the flow channel 432 is at leastpartially defined by the gap between the second plate member 430 and theperipheral portion 428 of the first plate member 430. In the illustratedembodiment, the gap extends around the entire periphery of the secondplate member 430. In other embodiments the gap can extend only partiallyaround the periphery of the second plate member 430.

The rotational control element 402 can be configured to control theamount of fluid flow through the flow channel 432 based on theorientation of the second plate member 430 relative to the first platemember 420. In some embodiments, the second plate member 430 can beconfigured to rotate about a rotational axis A₂ (e.g., in a clockwiseand/or counterclockwise direction) relative to the first plate member420. Optionally, the second plate member 430 can be rotatably coupled tothe first plate member 420, such as by a fastener (e.g., a pin, screw,pivot, etc.—not shown) received within an aperture 434 formed in thesecond plate member 430.

The second plate member 430 can have a shape configured such that thegeometry (e.g., size and/or shape) of the flow channel 432 changes asthe second plate member 430 rotates. As a result, fluid flow through theflow channel 432 can be selectively adjusted by rotating the secondplate member 430 to a plurality of different orientations. For example,rotation of the second plate member 430 can cause a cross-sectional areaof the flow channel 432 to increase or decrease. As another example,rotation of the second plate member 432 can cause one or more portionsof the flow channel 432 to become obstructed or unobstructed. As yetanother example, rotation of the second plate member 430 can cause theflow inlet 422 and/or flow outlet 424 to become obstructed orunobstructed. In the illustrated embodiment, the second plate member 430includes a protruding portion 436. When in a first orientation (e.g., asshown in FIG. 4C), the protruding portion 436 can be positioned awayfrom the flow outlet 424, thus allowing fluid flow therethrough withlittle or no obstruction. When rotated to a second orientation (e.g.,rotated clockwise), the protruding portion 436 can move near or adjacentthe flow outlet 424 and/or into a portion of the flow channel 432 nearthe flow outlet 424, thereby partially or completely obstructing fluidflow through the flow outlet 424.

Referring again to FIG. 4A, the rotation of the second plate member 430can be actuated by the actuation structure 404. In some embodiments, thesecond plate member 430 is coupled to the actuation structure 404 viaelongated member 405. For example, the first and second actuationelements 408 a-b can be coupled to the elongated member 405 to controlthe rotation thereof. The elongated member 405 can be coupled to thesecond plate member 430 such that rotation of the elongated member 405produces a corresponding rotation of the second plate member 430 (e.g.,in a clockwise or counterclockwise direction about rotational axis A₂).In other embodiments the elongated member 405 can be omitted such thatthe actuation structure 404 is directly coupled to the second platemember 430 to control the rotation thereof. The techniques by which theactuation structure 404 actuates the rotation of the elongated member405 and/or second plate member 430 can be identical or generally similarto the embodiments previously described with respect to FIGS. 2 and 3 .For example, the first and second actuation elements 408 a-b can includeshape memory materials configured to change in shape when heated torotate the elongated member 405 and/or second plate member 430.

It will be appreciated that the flow control assembly 400 can beconfigured in a number of different ways. For example, although FIG.4A-4C illustrate the first plate member 420 as having a generallycircular shape, in other embodiments the first plate member 420 can havea different shape (e.g., elliptical, square, rectangular, polygonal,etc.). The shape of the second plate member 430 can also be varied asdesired. Additionally, the geometry of the recessed portion 426 and/orsecond plate member 430 can be configured in a number of different waysto selectively modify the geometry and/or flow resistancecharacteristics of the flow channel 432. For example, in otherembodiments the protruding portion 436 can be located near the flowinlet 422 instead of the flow outlet 424, or the second plate member 430can include a plurality of protruding portions at different locationsrelative to the flow inlet 422, flow outlet 424, and/or flow channel432.

FIGS. 5A and 5B are a top view and a side cross-sectional view,respectively, of a flow control assembly 500 of an intraocular shuntingsystem configured in accordance with a further embodiment of the presenttechnology. Referring to FIGS. 5A and 5B together, the flow controlassembly 500 includes a rotational control element 502 coupled to anactuation structure 504 (the actuation structure 504 is omitted fromFIG. 5B merely for purposes of clarity). The rotational control element502 can include a first plate member 520 coupled to a second platemember 530. The first plate member 520 can be positioned beneath thesecond plate member 530. The first and second plate members 520, 530 caneach have a generally flattened shape (e.g., a circular, elliptical,square, rectangular, polygonal, or other shape). In the illustratedembodiment, the first and second plate members 520, 530 have the sameshape but with different sizes (e.g., the first plate member 520 islarger than the second plate member 530). In other embodiments, thefirst and second plate members 520, 530 can have different shapes.

The first plate member 520 can include a first flow channel 522. Thefirst flow channel 522 can be fluidly coupled to a location in the eye(e.g., a subconjunctival bleb space). As best seen in FIG. 5B, the firstflow channel 522 can include an exterior section 524 a located outsidethe first plate member 520 and an interior section 524 b formed in thefirst plate member 520. In the illustrated embodiment, the exteriorsection 524 a is coupled to a lateral surface 526 a of the first platemember 520 and the interior section 524 b extends through the firstplate member 520 from the lateral surface 526 a to an upper surface 526b of the first plate member 520. In other embodiments the exteriorsection 524 a can be coupled to a different portion of the first platemember 520 (e.g., to a different lateral surface or a bottom surface)and the interior section 524 b can extend through the first plate member520 from that portion to the upper surface 526 b. Alternatively, theexterior section 524 a can be omitted, such that the first flow channel522 only includes the interior section 524 b.

The second plate member 530 can include a second flow channel 532. Thesecond flow channel 532 can be fluidly coupled to an outflow portion ofa drainage element (e.g., for shunting fluid from the anterior chamberof the eye—not shown). As best seen in FIG. 5B, the second flow channel532 can include an exterior section 534 a located outside the secondplate member 530 and an interior section 534 b formed in the secondplate member 530. In the illustrated embodiment, the exterior section534 a is coupled to an upper surface 536 a of the second plate member530 and the interior section 534 b extends through the second platemember 530 from the upper surface 536 a to a lower surface 536 b of thesecond plate member 530. In other embodiments the exterior section 534 acan be coupled to a different portion of the second plate member 530(e.g., to a lateral surface) and the interior section 534 b can extendthrough the second plate member 530 from that portion to the lowersurface 526 b. Alternatively, the exterior section 534 a can be omitted,such that the second flow channel 532 only includes the interior section534 b.

In some embodiments, the second plate member 530 is configured torotatably move relative to the first plate member 520 (e.g., aboutrotational axis A₃) to change the position of the second flow channel532 relative to the first flow channel 522. As a result, depending onthe orientation of the second plate member 530 relative to the firstplate member 520, the first and second flow channels 522, 532 can bealigned with each other (e.g., as shown in FIG. 5B) to permit fluidtherethrough, or can be offset from each other to reduce or preventfluid flow therethrough. For example, when the first and second flowchannels 522, 532 are aligned, the interior section 524 b of the firstflow channel 522 can be aligned with and fluidly coupled to the interiorsection 534 b of the second flow channel 532, thereby creating anunobstructed flow path permitting fluid flow therethrough. As a result,fluid can flow from a portion of the eye (e.g., the anterior chamber),through the second flow channel 532, through the first flow channel 522,and out to a different location of the eye. Conversely, when the firstand second flow channel 522, 532 are offset from each other, theinterior section 524 b of the first flow channel 522 can be offset andfluidly decoupled from the interior section 534 b of the second flowchannel 532, thereby reducing or preventing fluid flow therethrough.

Referring again to FIG. 5A, the rotation of the second plate member 530can be actuated by the actuation structure 504. The actuation structure504 can include a first actuation element 508 a and a second actuationelement 508 b. In the illustrated embodiment, the first and secondactuation elements 508 a-b each include respective first end portions512 a, 514 a coupled to the second plate member 530 and respectivesecond end portions 512 b, 514 b coupled to the first plate member 520.In other embodiments, the first end portions 512 a, 514 a can be coupledto the first plate member 520 and the second end portions 512 b, 514 bcan be coupled to the second plate member 530. The first and secondactuation elements 508 a-b can each be elongated structures (e.g.,struts, springs such as flat springs or helical springs wrapped around aguidewire, coils, wires, etc.) extending at least partially along theperiphery of the second plate member 530. In the illustrated embodiment,the first and second actuation elements 508 a-b are positioned atopposite peripheral portions of the second plate member 530.

In some embodiments, the first and second actuation elements 508 a-binclude one or more shape memory materials configured to at leastpartially transition from a first phase/state (e.g., a martensitic orintermediate state) to a second phase/state (e.g., an intermediate oraustenitic state) upon application of energy, as previously described.The first and second actuation elements 208 a-b can each be configuredto change in shape or otherwise transform between a first configuration(e.g., a memory shape, a preferred geometry, etc.) and a secondconfiguration (e.g., a shape different from the memory shape, a deformedgeometry, etc.) via a shape memory effect (e.g., when heated) to drivethe rotation of the second plate member 530. For example, in someembodiments, the memory shape is a lengthened configuration, while inother embodiments the memory shape is a shortened configuration.

For example, in the illustrated embodiment, the first actuation element508 a is configured to transform to a lengthened configuration whenheated to rotate the second plate member 530 along a first direction(e.g., clockwise), and the second actuation element 508 b is configuredto transform to a lengthened configuration when heated to rotate thesecond plate member 530 along a second, opposite direction (e.g.,counterclockwise). Alternatively or in combination, the first actuationelement 508 a can be configured to transform to a shortenedconfiguration when heated to rotate the second plate member 530 along afirst direction (e.g., counterclockwise), and the second actuationelement 508 b can be configured to transform to a lengthenedconfiguration when heated to rotate the second plate member 530 along asecond, opposite direction (e.g., clockwise). Optionally, the first andsecond actuation elements 508 a-b can be configured to oppose eachother, such that actuation of one actuation element via the shape memoryeffect produces a corresponding deflection and/or deformation in theother actuation element. For example, transformation of one actuationelement into a lengthened configuration can cause the other actuationelement to transform into a shortened configuration, and/ortransformation of one actuation element into a shortened configurationcan cause the other actuation element to transform into a lengthenedconfiguration. The changes in shape of the first and second actuationelements 508 a-b can drive the rotation of the first plate member 530 tocontrol the alignment of the first and second flow channels 522, 532.

FIGS. 6A-6C illustrate a flow control assembly 600 of an intraocularshunting system configured in accordance with another embodiment of thepresent technology. More specifically, FIG. 6A is a front view of theassembly 600 in an unloaded and/or uncompressed configuration, FIG. 6Bis a front view of the assembly 600 in a loaded and/or compressedconfiguration, and FIG. 6C is a front view of the assembly 600 in arotated configuration.

Referring to FIGS. 6A-6C together, the flow control assembly 600includes a frame structure 602. The frame structure 602 can include afirst strut 604 a and a second strut 604 b coupled to each other by anupper segment 606. The first and second struts 604 a-b can each have agenerally linear shape. The first and second struts 604 a-b can eachextend along a longitudinal axis of the frame structure 602 and couplerespectively to first and second curved segments 608 a-b. The first andsecond curved segments 608 a-b can be connected to each other by a basesegment 610. The base segment 610 can be coupled to a pin element 612.The pin element 612 can be an elongated, generally linear structure thatextends along the longitudinal axis of the frame structure 602 towardsthe upper segment 606 and terminates in an end portion 614. In someembodiments, the first and second struts 604 a-b, upper segment 606,first and second curved segments 608 a-b, base segment 610, and pinelement 612 are integrally formed with each other such that the framestructure 602 is manufactured as a single unitary component. In otherembodiments, one or more of the components of the frame structure 602are manufactured separately and subsequently coupled to each other toform the frame structure 602.

The frame structure 602 can initially be in a fabricated ornon-tensioned configuration (e.g., an unloaded and/or uncompressedconfiguration as shown in FIG. 6A) in which the pin element 612 ispositioned away from the upper segment 606. The frame structure 602 cansubsequently be placed into a tensioned configuration (e.g., a loadedand/or compressed configuration as shown in FIG. 6B) by moving the basesegment 610 and pin element 612 towards the upper segment 606 until theend portion 614 of the pin element 612 is engaged with a retentionfeature 616 formed in the upper segment 606. For example, the retentionfeature 616 can be a notch, groove, aperture, or any other structuresuitable for retaining end portion 614 therein. The end portion 614 ofthe pin element 612 can include a flange, lip, protrusion, or any otherstructure suitable for engaging the retention feature 616 to secure thepin element 612 thereto. In some embodiments, the frame structure 602 ismanufactured in the non-tensioned configuration and subsequently placedinto the tensioned configuration for use (e.g., prior to, concurrentlywith, or after implantation in the patient's eye).

In some embodiments, the base segment 610 serves as a rotational controlelement for selectively controlling fluid flow through a drainageelement (e.g., for shunting fluid from the anterior chamber of theeye—not shown). For example, the base segment 610 can be positioned nearor adjacent to one or more apertures of an outflow or inflow portion ofthe drainage element (not shown). When in a first orientation (e.g., asshown in FIG. 6B), the base segment 610 can partially or completelycover the aperture(s) to partially or completely obstruct fluid flowtherefrom. When rotated to a second orientation (e.g., along acounterclockwise direction as shown in FIG. 6C), the base segment 610can be spaced apart from the aperture(s) to permit fluid flow therefromwith little or no obstruction.

The first curved segment 608 a and/or second curved segment 608 b canserve as an actuation structure for rotating the base segment 610 toselectively adjust fluid flow. In the illustrated embodiment, forexample, the second curved segment 608 b is made from one or more shapememory materials configured to at least partially transition from afirst phase/state (e.g., a martensitic or intermediate state) to asecond phase/state (e.g., an intermediate or austenitic state) uponapplication of energy, as previously described. When the energy isapplied, the second curved segment 608 b can undergo a phase transitioncausing it to stiffen and/or change in shape to a contractedconfiguration. As a result, the base segment 610 can rotate/pivot alonga counterclockwise direction towards the second curved segment 608 b,e.g., as shown in FIG. 6C and indicated by arrow A. Optionally, in someembodiments, the first curved segment 608 a is also made from a shapememory material configured to actuate rotation of the base segment 610.When energy is applied to the first curved segment 608 a, it can stiffenand/or change in shape to a contracted configuration, thus causing thebase segment 610 to rotate/pivot along a clockwise direction towards thefirst curved segment 608 a. As a result, the first and second curvedsegments 608 a-b can oppose each other to allow the base segment 610 tobe rotated/pivoted in two opposite directions.

FIGS. 7A-7E illustrate an intraocular shunting system 10 (the “system10”) configured in accordance with select embodiments of the presenttechnology. More specifically, FIG. 7A is a front view of the system 10,FIG. 7B is an enlarged front view of a flow control assembly 700 of thesystem 10 taken from the region identified in FIG. 7A, FIG. 7C is anenlarged front view of an actuator 701 a of the flow control assembly700, FIG. 7D is an enlarged front view of the actuator 701 in a firstconfiguration, and FIG. 7E is an enlarged front view of the actuator 701in a second, different configuration.

Referring first to FIG. 7A, the system 10 includes a flow controlassembly 700 and a casing, plate, or drainage element 750. The drainageelement 750 can extend between a first end portion 750 a and a secondend portion 750 b, and can have a generally flat profile. When implantedin a patient's eye, the first end portion 750 a can reside at leastpartially within an interior region of the eye (e.g., the anteriorchamber), and the second end portion 750 b can reside at least partiallywithin and/or be in fluid communication with a desired outflow location(e.g., a subconjunctival bleb space).

In some embodiments, the drainage element 750 can include multiplediscrete components. For example, the drainage element 750 may include agenerally rigid inner structure 751 (e.g., a plastic or other rigidblock, plate, etc.) that encases or is configured to encase the flowcontrol assembly 700 and is positioned at the first end portion 750 a ofthe drainage element 750. The drainage element 750 may further include asemi-flexible outer structure 753 (e.g., a silicone or other flexibleshell, casing, etc.) that holds the first inner structure and extendsbetween the first end portion 750 a and the second end portion 750 b ofthe drainage element 750. For example, the generally rigid innerstructure 751 can have a length between about 1 mm to about 5 mm, suchas between about 2 mm and 3 mm, and the semi-flexible outer structure753 may have a length between about 6 mm and about 13 mm, such asbetween about 8 mm and 10 mm. In such embodiments, the generally rigidinner structure 751 may form a fluid seal with the semi-flexible outerstructure 753 to prevent fluid from leaking therebetween.

The drainage element 750 can have a plurality of lumens or channelsextending between the first end portion 750 a and the second end portion750 b. In the illustrated embodiment, for example, the drainage element750 includes a first channel 752 a, a second channel 752 b, and a thirdchannel 752 c (collectively referred to herein as the channels 752). Asdescribed in greater detail below, aqueous can drain through thechannels 752 from the anterior chamber to the desired outflow locationwhen the system 10 is implanted in the patient's eye. The channels 752can have the same or different cross-sectional dimensions and/or areas.For example, in some embodiments the first channel 752 a has a firstdiameter, the second channel 752 b has a second diameter greater thanthe first diameter, and the third channel 752 c has a third diametergreater than the second diameter. In embodiments in which the channels752 have different dimensions (e.g., diameters), the fluid resistancethrough each of the channels 752 may be different. Although shown ashaving three channels 752, the system 10 can include more or fewerchannels 752, such as one, two, four, five, six, seven, eight, or more.

As described in greater detail with respect to FIG. 7B, the flow controlassembly 700 can include one or more actuators for controlling the flowof aqueous into the channels 752. For example, the flow control assembly700 can include a first actuator 701 a for controlling the flow ofaqueous through the first channel 752 a, a second actuator 701 b forcontrolling the flow of aqueous through the second channel 752 b, and athird actuator 701 c for controlling the flow of aqueous through thethird channel 752 c (collectively referred to as the actuators 701).Although shown as having three actuators 701, the system 10 can includemore or fewer actuators 701, such as one, two, four, five, six, seven,eight, or more. In some embodiments, the number of actuators 701 can besame as the number of channels 752, although in other embodiments thesystem 10 can have a different number of actuators 701 and channels 752.In some embodiments, the system 10 includes a single actuator 701 forcontrolling flow through a single channel extending through a drainageelement.

Referring now to FIG. 7B, the actuators 701 are positioned in respectivechambers defined by the drainage element 750 and one or more internalwall structures 730 (e.g., which may be part of the generally rigidinner structure 751). For example, the first actuator 701 a ispositioned in a first chamber 732 a, the second actuator 701 b ispositioned in a second chamber 732 b, and the third actuator 701 c ispositioned in a third chamber 732 c (collectively referred to herein aschambers 732). The first chamber 732 a can be in fluid communicationwith the first channel 752 a (e.g., via a first port 734 a), the secondchamber 732 b can be in fluid communication with the second channel 752b (e.g., via a second port 734 b), and the third chamber 732 c can be influid communication with the third channel 752 c (e.g., via a third port734 c). In some embodiments, the chambers 732 can be fluidly isolatedfrom one another to prevent fluid from flowing between the chambers 732.As provided below, fluidly isolating the chambers 732 enables the system10 to provide a more titratable/granular therapy by enabling ahealthcare provider to select between a plurality of therapy levels.

The drainage element 750 can include a first fluid inlet 716 a (shown asa single aperture 716 a) that in at least some configurations canfluidly connect the first chamber 732 a to an environment external tothe first end portion 750 a of the drainage element 750. The drainageelement 750 can further include a second fluid inlet 716 b (shown as twoapertures) that in at least some configurations can fluidly connect thesecond chamber 732 b to the environment external to the first endportion 750 a of the drainage element 750. The drainage element 750 canfurther include a third fluid inlet 716 c (shown as four apertures 716c) that in at least some configurations can fluidly connect the thirdchamber 732 c to the environment external to the first end portion 750 aof the drainage element 750. When the system 10 is implanted in the eye,the environment external to the first end portion 750 a of the drainageelement 750 can include the anterior chamber of the eye. Accordingly, inat least some configurations, aqueous can flow into the chambers 732 viathe respective fluid inlets in the drainage element 750. The aqueous canthen drain from the chambers 732 via the respective channels 752. Asdescribed in greater detail below, the fluid resistance of the system10, and thus the drainage of aqueous through the system 10, can beselectively controlled by selectively blocking and/or unblocking thefluid inlets 716 by selectively actuating the actuators 701.

The drainage element 750 can also include a first transmission region756 a and a second transmission region 756 b (collectively referred toas transmission regions 756). In some embodiment, the transmissionregions 756 can have a lower absorbance than the surrounding structuresuch that energy (e.g., light, laser energy, etc.) can pass through thetransmission region with relatively less absorbance or deflection. Insome embodiments, the transmission regions 756 can be a differentmaterial and/or different properties than the surrounding structure. Insome embodiments, the transmission regions 756 are composed of the samematerial as the surrounding structure, but nevertheless provide a targetfor a user to direct energy toward. In some embodiments, thetransmission regions 756 are an opening in the drainage element 750.When the first actuator 701 a is secured to the drainage element 750,target regions on the first actuator 701 a align with the transmissionregions 756, as described below. This enables energy delivered from asource external to the drainage element 750 to pass through thetransmission regions 756 and energize (e.g., heat) the targets.

The drainage element 750 can further include a window 758. The window758 may be composed of a transparent or semi-transparent material thatpermits a user (e.g., a physician) to visualize the orientation of theactuators 701. In some embodiments, the window 758 may align with thetarget regions of the actuators 701, and the transmission regions 756can be omitted. In embodiments in which the drainage element 750includes the generally rigid inner structure 751 and the semi-flexibleouter structure 753, the window 758 may be an opening in thesemi-flexible outer structure 753, and the fluid inlets 716 may be inthe generally rigid inner structure 751.

The first actuator 701 a includes a projection 702 (e.g., a finger, atongue, a lever, a gating element, a control element, etc.), a firstactuation element 708 a, a second actuation element 708 b, a firsttarget 710 a, and a second target 710 b. The first actuation element 708a extends between the first target 710 a and a proximal region 702 a ofthe projection 702, and the second actuation element 708 b extendsbetween the second target 710 b and the proximal region 702 a of theprojection 702. The projection 702 extends from the proximal region 702a to a distal region 702 b configured to interface with the first fluidinlet 716 a to control the flow of fluid therethrough. In theillustrated embodiment, the projection 702 extends toward the firsttarget 710 a and the second target 710 b (e.g., the distal region 702 bis between the proximal region 702 a and the first and second targets).In other embodiments, the projection 702 extends away from the firsttarget 710 a and the second target 710 b (e.g., the proximal region 702a is between the distal region 702 b and the first and second targets).In such embodiments, the first fluid inlet 716 a would also bepositioned distally (e.g., closer to the first port 734 a and the firstchannel 752 a) such that the distal region 702 b still is configured tointerface with the first fluid inlet 716 a. Regardless of itsorientation, the distal region 702 b of the projection is a free end(e.g., it is not connected to another portion of the first actuator 701a or other portion of the system 700) such that it canpivotably/rotatably move relative to the drainage element 750 and thefirst fluid inlet 716 a, as described in greater detail below. In someembodiments, the first actuation element 708 a and the second actuationelement 708 b are connected via a connector region. In such embodiments,the projection 702 can extend from the connector region. The connectorregion can be contiguous with the first actuation element 708 a, thesecond actuation element 708 b, and/or the projection 702, or can be aseparate element coupled to the first actuation element 708 a, thesecond actuation element 708 b, and/or the projection 702 via suitableconnection techniques.

The first actuator 701 a can be secured to or otherwise at leastpartially restrained relative to the drainage element 750. For example,in the illustrated embodiment, the proximal region 702 a of theprojection 702 is pivotably/rotatably secured to the drainage element750 via a restraint 720 (e.g., an anchor, pin, etc.) such that theprojection 702 can pivot/rotate relative to the drainage element 750.Accordingly, the projection 702 can also be referred to as a rotationalcontrol element. In some embodiments, the proximal region 702 a caninclude an aperture (not shown) through which the restraint 720 can beinserted to facilitate coupling of the proximal region 702 a to thedrainage element 750 via the restraint 720.

The first target 710 a is secured to drainage element 750 via a firsttarget first restraint 724 a (e.g., an anchor, pin, etc.) and acorresponding first aperture 712 a in the first target 710 a. The firsttarget first restraint 724 a and the first aperture 712 a are shown asdecoupled in FIG. 7B to more clearly illustrate both components.However, as shown in FIG. 7C—which illustrates the first actuator 701 aand select restraints with the other features of the system 10 omittedfor clarity—the first target first restraint 724 a is configured toextend through the first aperture 712 a (not visible in FIG. 7C) tosecure the first target 710 a to the drainage element 750. Accordingly,securing the first actuator 701 a to the drainage element 750 thereforeincludes deforming it (e.g., stretching it) relative to its preferred orfabricated geometry such that the first aperture 712 a aligns with thefirst target first restraint 724 a, and securing it to the drainageelement using one or more pins or anchors. As described in greaterdetail below, this deformation tensions the first actuation element 708a and prepares it to undergo a geometric change when the first target710 a is heated. The second target 710 b is also secured to the drainageelement 750 via a second target first restraint 724 b and acorresponding second aperture 712 b in the second target 710 b. Thesecond target first restraint 724 b and the second aperture 712 b areshown as decoupled in FIG. 7B to more clearly illustrate bothcomponents. However, as shown in FIG. 7C, the second target firstrestraint 724 b is configured to extend through the second aperture 712b (not visible in FIG. 7C) to secure the second target 710 b to thedrainage element 750. Accordingly, securing the first actuator 701 a tothe drainage element 750 therefore includes deforming it (e.g.,stretching it) relative to its preferred or fabricated geometry suchthat the second aperture 712 b aligns with the second target firstrestraint 724 b, and securing it to the drainage element 750 using oneor more pins or anchors. As described in greater detail below, thisdeformation tensions the second actuation element 708 b and prepares itto undergo a geometric change when the second target 710 b is heated.

Accordingly, in the illustrated embodiment, the first actuator 701 a isanchored to the drainage element 750 in at least three locations/regions(e.g., at the first target 710 a, at the second target 710 b, and at theproximal region 702 a of the projection 702). Without being bound bytheory, anchoring the first actuator 701 a to the drainage element 750at three locations or regions permits the first actuator 701 a tooperate via a pivoting motion that, as described below, can translate arelatively small movement of a first portion of the actuator (e.g., thefirst actuation element 708 a) into a relatively large movement of asecond portion of the actuator (e.g., the distal region 702 b of theprojection 702). Anchoring the first actuator 701 a at three locationsalso permits the first target 710 a and the second target 710 b to besubstantially thermally isolated (as opposed to if the first target 710a and the second target 710 b were directly connected and anchored at asingle location), which enables the first actuation element 708 a andthe second actuation element 708 b to be selectively and independentlyactuated. In other embodiments, the first actuator 701 a can be anchoredto the drainage element 750 at fewer or more positions, such as one,two, four, five, six, seven, eight, or more locations. Moreover,although shown as being anchored by first and second restraints 724,726, the first and second targets 710 a, 710 b can be anchored via othersuitable means. For example, in some embodiments the first and secondtargets 710 a, 710 b can be connected to an interior surface of thedrainage element 750 via an adhesive (e.g., glue, tape, staple, etc.).

As best shown in FIG. 7C, the first target 710 a can also be at leastpartially restrained by a first target second restraint 726 a, and thesecond target 710 b can also be at least partially restrained by asecond target second restraint 726 b. The first target second restraint726 a does not necessarily directly couple the first actuator 701 a tothe drainage element 750, but rather reduces or prevents the firsttarget 710 a and/or the second actuation element 708 a from rotating orbending inwardly toward the projection 702. Likewise, the second targetsecond restraint 726 b does not necessarily directly couple the firstactuator 701 a to the drainage element 750, but rather reduces orprevents the second target 710 b from rotating or bending inwardlytoward the projection 702.

In some embodiments, the first actuation element 708 a may optionally beat least partially restrained by a first actuation element restraint 728a, and the second actuation element 708 b may optionally be at leastpartially restrained by a second actuation element restraint 728 b. Likethe first target second restraint 726 a, the first actuation elementrestraint 728 a does not necessarily directly couple the first actuationelement 708 a to the drainage element 750, but nevertheless can preventor reduce the first actuation element 708 a from bowing or otherwisemigrating inwardly toward the projection 702. Likewise, the secondactuation element restraint 728 b does not necessarily directly couplethe second actuation element 708 b to the drainage element 750, butnevertheless can prevent or reduce the second actuation element 708 bfrom bowing or otherwise migrating inwardly toward the projection 702.As a result of the first actuation element restraint 728 a, the firstactuation element 708 a includes a first (e.g., generally linear) region708 a ₁ extending from the first target 710 a and a second (e.g.,non-linear or curved region) 708 a ₂ extending between the first region708 a ₁ and the projection 702. Likewise, as a result of the secondactuation element restraint 728 b, the second actuation element 708 bincludes a first (e.g., generally linear) region 708 b ₁ extending fromthe second target 710 b and a second (e.g., non-linear or curved region)region 708 b ₂ extending between the first region 708 b ₁ and theprojection 702. The first actuation element 708 a and the secondactuation element 708 b may also be at least partially constrained bythe walls 730 shown in FIG. 7B (e.g., preventing external bending orflexion of the first region 708 a ₁ and the first region 708 b ₁). By atleast partially constraining the actuation elements 708 from flexinginwardly or outwardly in the first regions 708 a ₁, 708 b 1, more of thestrain in the actuator 701 a is translated into a larger displacement ofthe projection 702 during actuation of the first actuator 701 a,described below.

The first actuation element 708 a and the second actuation element 708 bgenerally act in opposition. For example, as described in greater detailbelow, the first actuation element 708 a can be actuated to rotate theprojection 702 in a first direction (e.g., clockwise) to change (e.g.,decrease) the fluid resistance through the first fluid inlet 716 a(e.g., by unblocking, at least partially unblocking, or furtherunblocking the first fluid inlet 716 a). The second actuation element708 b can be actuated to rotate the projection 702 in a second direction(e.g., counterclockwise) generally opposite the first direction tochange (e.g., increase) the fluid resistance through the first fluidinlet 716 b (e.g., by blocking, further blocking, and/or interferingwith the first fluid inlet 716 a).

To facilitate the foregoing movement of the projection 702, the firstactuator 701 a can be composed at least partially of a shape memorymaterial or alloy (e.g., nitinol). Accordingly, the first actuator 701 a(and/or select regions thereof) can be transitionable at least between afirst material phase or state (e.g., a martensitic state, a R-phase, acomposite state between martensitic and R-phase, etc.) and a secondmaterial phase or state (e.g., an austenitic state, an R-phase state, acomposite state between austenitic and R-phase, etc.). In the firstmaterial state, the first actuator 701 a or select region thereof may bedeformable (e.g., plastic, malleable, compressible, expandable, etc.).In the second material state, the first actuator 701 a or select regionthereof may have a preference toward a specific preferred geometry(e.g., original geometry, manufactured or fabricated geometry, heat setgeometry, etc.). As described in greater detail below, select regions ofthe first actuator 701 a can be transitioned between the first materialstate and the second material state by applying energy (e.g., heat) tothe first actuator 701 a to heat the assembly above a transitiontemperature. In some embodiments, the transition temperature is atemperature greater than an average body temperature (e.g., an averagetemperature in a human eye).

In some embodiments, the first actuation element 708 a and the secondactuation element 708 b of the first actuator 701 a can be selectivelyand independently actuated (e.g., transitioned between the firstmaterial state and the second material state). For example, to actuatethe first actuation element 708 a, heat/energy can be applied to thefirst target 710 a, such as from an energy source positioned external tothe patient's eye (e.g., a laser). The heat applied to the first target710 a spreads through at least a portion of the first actuation element708 a, which can heat the first actuation element 708 a above itstransition temperature. To actuate the second actuation element 708 bheat/energy can be applied to the second target 710 b. The heat appliedto the second target 710 b spreads through the second actuation element708 b, which can heat at least the portion of the second actuationelement 708 b above its transition temperature.

FIGS. 7D and 7E illustrate the first actuator 701 a after actuation ofthe first actuation element 708 a and the second actuation element 708b, respectively. If the first actuation element 708 a is deformedrelative to its preferred geometry (e.g., as shown in FIG. 7B),actuating the first actuation element 708 a causes the first actuationelement 708 a to move toward its preferred geometry. For example, if thefirst actuation element 708 a is stretched (e.g., tensioned) relative toits preferred geometry, actuating the first actuation element 708 acauses it to contract (e.g., shorten). The contraction of the firstactuation element 708 a generally occurs in the second non-linear region708 a ₂ because the first generally linear region 708 a ₁ is held inplace via one or more restraints (e.g., the first actuation elementrestraint 728 a). Additionally, because the first actuator 701 a isrotatably coupled to the drainage element 750 at the restraint 720,contracting the first actuation element 708 a induces a rotationalmotion in the projection 702. In particular, the distal region 702 b ofthe projection 702 is rotated in a clockwise direction (as shown byarrow A) toward the second actuation element 708 b. This can transitionthe projection 702 from a first position in which it confers a firstfluid resistance through the first fluid inlet 716 a to and/or toward asecond position in which it confers a second fluid resistance throughthe first fluid inlet 716 b that is less than the first fluidresistance. For example, the projection 702 may block or substantiallyblock the first fluid inlet 716 a in the first position, and unblock orat least partially unblock the first fluid inlet 716 a in the secondposition. Following actuation of the first actuation element 708 a, theprojection 702 may recoil (e.g., rotate in a counterclockwise direction)at least slightly toward the first position, but nevertheless remainsrotated downwardly relative to the first position such that the firstfluid inlet 716 a remains at least partially unblocked. In otherembodiments, the projection 702 remains in the second position withoutexhibiting substantial recoil. In addition to moving the projection 702toward the second actuation element 708 b, actuating the first actuationelement 708 a can also induce a corresponding deformation (e.g.,stretching, lengthening, tensioning, etc.) in the second actuationelement 708 b, which remains in the first material state and thus isgenerally malleable (e.g., actuating the first actuation element 708 adecreases strain in the first actuation element 708 a and increasesstrain in the second actuation element 708 b).

The operation can be reversed by actuating the second actuation element708 b, causing it to contract (e.g., shorten) toward its preferredgeometry, as shown in FIG. 7E. The contraction of the second actuationelement 708 b predominantly occurs in the second non-linear region 708 b₂ because the first generally linear region 708 b ₁ is held in place viaone or more restraints (e.g., the second actuation element restraint 728b). Because the first actuator 701 a is rotatably secured at restraint720, contracting the second actuation element 708 b induces a rotationalmotion in the projection 702. In particular, the distal region 702 b ofthe projection 702 is rotated in a counterclockwise direction (as shownby arrow B) toward the first actuation element 708 a. This cantransition the projection 702 from the second position conferring thesecond relatively lower fluid resistance through the first fluid inlet716 a to and or toward the first position conferring the firstrelatively higher fluid resistance through the first fluid inlet 716 a.In some embodiments, the projection 702 may rotate in a counterclockwisedirection to a third position between the first fluid inlet 716 a andthe first actuation element 708 a when the second actuation element 708b is actuated. Accordingly, in some embodiments the system 10 includes amechanical or other stopping feature that is configured to prevent theprojection 702 from rotating too far in the counterclockwise direction,which may cause the projection 702 to not block the first fluid inlet716 a upon actuation of the second target 710 b. The mechanical stop canbe configured to stop counterclockwise rotation of the projection 702once the projection 702 blocks or substantially blocks the first fluidinlet 716 a following actuation of the second actuation element 708 b.

Accordingly, the first actuation element 708 a and the second actuationelement 708 b can be selectively and independently actuated to block orunblock the first fluid inlet 716 a to control the flow of fluidtherethrough. In some embodiments, the projection 702 can be moved toany number of positions between fully blocking and fully unblocking thefirst fluid inlet 716 a to provide a variety of different outflowresistance levels by incrementally adjusting the projection 702 relativeto the first fluid inlet 716 a. Additional details regarding theoperation of shape memory actuators are described in U.S. PatentPublication No. 2020/0229982 and International Patent Application Nos.PCT/US20/55144 and PCT/US20/55141, the disclosures of which areincorporated by reference in their entireties.

In some embodiments, the first actuator 701 a can be a unitary orintegral structure (e.g., fabricated from a single piece of material,fabricated using a vapor deposition process, etc.). To assemble the flowcontrol assembly 700, the first actuator 701 a can be tensioned (e.g.,stretched, lengthened, expanded, etc.) and secured to the drainageelement 750 via the restraints while in the first material state. Thisat least partially deforms the actuation elements 708 relative to theirpreferred geometries. For example, as described above, both the firstactuation element 708 a and the second actuation element 708 b arestretched (e.g., lengthened) relative to their preferred geometries whenloaded onto the drainage element 750. In other embodiments, the firstactuator 701 a can be compressed and secured to the drainage element750, rather than tensioned.

Although the foregoing description is directed to the first actuator 701a, the description can also apply to the second actuator 701 b and/orthe third actuator 701 c. Accordingly, the second actuator 701 b and/orthe third actuator 701 c can be the same as, or at least substantiallysimilar to, the first actuator 701 a. The drainage of aqueous throughthe system 10 can therefore be selectively controlled by selectivelyblocking and/or unblocking the fluid inlets 716 using the actuators 701.For example, to provide a first level of therapy having a first drainagerate and a first flow resistance, the first fluid inlet 716 a can beaccessible/unblocked, while the second fluid inlet 716 b and the thirdfluid inlet 716 c remain inaccessible/blocked. To provide a second levelof therapy having a second drainage rate that is greater than the firstdrainage rate (e.g., a second flow resistance less than the first flowresistance), the second fluid inlet 716 b can be accessible/unblocked,while the first fluid inlet 716 a and the third fluid inlet 716 c remaininaccessible/blocked. To provide a third level of therapy having a thirddrainage rate greater than the second drainage rate (e.g., a third flowresistance less than the first flow resistance), the first fluid inlet716 a and the second fluid inlet 716 b can be unblocked while the thirdfluid inlet 716 c remains blocked. As one skilled in the art willappreciate, the flow control assembly 700 can be actuated such that anycombination of the first fluid inlet 716 a, the second fluid inlet 716b, and the third fluid inlet 716 c are blocked or unblocked to provideat least eight different therapy levels (ranging from all three fluidinlets blocked to all three fluid inlets unblocked).

In some embodiments, the resistances provided by each individual channel752 can have a predetermined ratio. For example, the resistance providedby the third channel 752 c when the third fluid inlet 716 c isunblocked, the resistance provided by the second channel 752 b when thesecond fluid inlet 716 b is unblocked, and the resistance provided bythe first channel when the first fluid inlet 716 a is unblocked can havea ratio of 1:2:4. In some embodiments, for a given pressure, the flowrate through the system 10 when only the first fluid inlet 716 a isunblocked can be about X, the flow rate through the system when only thesecond fluid inlet 716 a is unblocked can be about 2×, and the flow ratethrough the system when only the third fluid inlet 716 c is unblockedcan be about 4×. In this way, the pattern of resistances (and drainagerates) that can be achieved using the system 10 can be adjustedaccording to a known pattern. For example, the actuators 701 can beactuated such that any combination of fluid inlets 716 are blocked andunblocked, thereby providing any flow rate between X (only the firstfluid inlet 716 a is unblocked) and 7× (all the fluid inlets 716 areunblocked). Additional details regarding the ability to provide aplurality of therapy levels using intraocular shunting systems having avariety of fluid inlets are described in International PatentApplication No. PCT/US21/14774, the disclosure of which is incorporatedby reference herein in its entirety.

In some embodiments, the therapy level (e.g., drainage rate, flowresistance, etc.) is determined by the relative dimensions of thechannels 752, not the number or size of the fluid inlets 716. Forexample, as previously described, the channels 752 can have differentdimensions. In some embodiments, a diameter or other cross-sectionalarea of the first channel 752 a is smaller than a diameter or othercross-sectional area of the second channel 752 b, which itself issmaller than a diameter or other cross-sectional area of the thirdchannel 752 c. In embodiments in which the flow resistance is determinedby the channels 760, the fluid inlets 716 can nevertheless include adifferent number of apertures to provide a visual cue to the healthcareprovide reflecting the relative fluid resistances of the correspondingchannel (e.g., one aperture means the corresponding fluid channel has afirst resistance, two apertures means the corresponding fluid channelhas a second resistance less than the first, etc.). In otherembodiments, the fluid inlets 716 can include another visual cue orindicator to reflect the relative fluid resistances of the correspondingchannel.

Without being bound by theory, using a rotational/pivotable motion toselectively block and/or unblock the fluid inlets 716 is expected toprovide several advantages relative to actuators operating via linearmotion. For example, a relatively small motion in the actuation elements708 can be translated into a relatively large motion of the distalregion 702 b of the projection 702. Without being bound by theory, thisis expected to decrease the amount of strain required in the first andsecond actuation elements 708 to move the projection 702 (e.g., to blockand/or unblock the fluid inlets 716). In turn, this may further increasethe consistency of motion of the projection 702 as compared to anactuator with linearly arranged actuation elements.

FIGS. 8A-8C illustrate an intraocular shunting system 20 (the “system20”) configured in accordance with select embodiments of the presenttechnology. More specifically, FIG. 8A is a front view of the system 20,FIG. 8B is a side view of the system 20, and FIG. 8C is an enlargedfront view of a flow control assembly 800 of the system 20 taken alongthe lines indicated in FIG. 8A. The system 20 can be generally similarto the system 10 described with respect to FIGS. 7A-7E. For example,referring to FIG. 8A, the system 20 can include a drainage element 850and a flow control assembly 800. The drainage element 850 can extendbetween a first end portion 850 a and a second end portion 850 b, andcan have a generally flat profile. The drainage element 850 can furtherinclude one or more channels 852 extending between the first end portion850 a and the second end portion 850 b. When implanted in a patient'seye, the first end portion 850 a can reside at least partially within aninterior region of the eye (e.g., an anterior chamber), and the secondend portion 850 b can reside at least partially within and/or be influid communication with a desired outflow location (e.g., asubconjunctival bleb space). The drainage element 850 can optionallyinclude one or more wings or appendages 860 having holes (e.g. sutureholes) for securing the drainage element 850 in a desired position. Asbest shown in FIG. 8B, the drainage element 850 can have a generallycurved profile to better conform to the anatomy of the eye.

Referring to FIG. 8C, the flow control assembly 800 can include a firstactuator 801 a and a second actuator 801 b (collectively referred to asthe “actuators 801”). The actuators 801 can be generally similar to theactuators 701 described with respect to FIGS. 7A-7E. For example, thefirst actuator 801 a can include a projection 802 (e.g., a finger, atongue, a lever, a gating element, a control element, etc.), a firstactuation element 808 a, a second actuation element 808 b, a firsttarget 810 a, and a second target 810 b. The first actuator 801 a can berestrained and/or secured to the drainage element 850 via a firstrestraint 820, a second restraint 822, and a third restraint 824. Theprojection 802 can rotate/pivot about the first restraint 820, asdescribed above with respect to FIGS. 7A-7E. However, unlike theactuators 701, the first actuator 801 a can also rotate/pivot around thesecond restraint 822 and the third restraint 824. Accordingly, theactuators 801 can rotate at three locations (e.g., the first actuator801 a has three rotational degrees of freedom).

FIGS. 9A-9D illustrate an actuator 901 for controlling the flow of fluidin a shunting system and configured in accordance with selectembodiments of the present technology. More specifically, FIG. 9A is anisometric view of the actuator 901, FIG. 9B is a top view of theactuator 901 in a fabricated or non-tensioned configuration, FIG. 9C isa top view of the actuator 901 in a tensioned configuration, and FIG. 9Dis a top view of the actuator 901 in an actuated configuration. Theactuator 901 is shown in isolation for clarity. However, as one skilledin the art will appreciate, the actuator 901 can be used in systemssimilar to the system 10 or the system 20 described with reference toFIGS. 7A-7E and FIGS. 8A-8C, respectively (e.g., instead of actuators701 and 801, respectively). Moreover, the actuator 901 can operate in amanner generally similar to the actuator 701 (FIGS. 7A-7E) and theactuator 801 (FIGS. 8A-8C) previously described. Accordingly, thefollowing description places particular focus on features and functionsof the actuator 901 that are different than those previously described.

Referring first to FIG. 9A, the actuator 901 includes a projection 902,a first actuation element 908 a, and a second actuation element 908 b(collectively referred to as the “actuation elements 908”). Inoperation, the actuation elements 908 can be selectively andindependently actuated to rotate the projection 902 to block (e.g.,interfere with, partially interfere with, etc.) or unblock (e.g., clear,avoid, etc.) a fluid inlet (e.g., the fluid inlet 716 of the system 10,shown in FIG. 7A) for controlling the flow of fluid therethrough, aspreviously described herein. The projection 902 can include selectfeatures that in at least some embodiments increase the efficiencyand/or flow control imparted by the actuator 901. For example, theprojection 902 can include a blocking feature 905 positioned at itsdistal region 902 b. The blocking feature 905 can have an enlargedsurface area or volume to better enable the projection 902 to interfacewith one or more fluid inlets (e.g., the fluid inlets 716 of the system10) when in a “closed” position to control the flow of fluidtherethrough. The blocking feature 905 can nevertheless be configured topermit fluid flow through the one or more fluid inlets when in an “open”position. The projection 902 can also have a neck region 903 at itsproximal region 902 a that has a thinner cross-section than otherportions of the projection 902. Strain induced by the projection 902contacting another portion of the actuator 901 during operation can bepreferentially minimized by the neck region 903, rather than beingconcentrated into other portions of the actuator 901 (e.g., theactuation elements 908). This is expected to improve the reproducibilityand consistency of motion that can be induced during actuation of theactuator 901.

The actuator 901 also includes a first target 910 a and a second target910 b (collectively referred to as the “targets 910”) for receivingenergy to power the actuation elements 908. Unlike the actuatorsdescribed with respect to FIGS. 7A-8C, the targets 910 of the actuator901 are positioned along the respective actuation elements 908. Inparticular, the first target 910 a is positioned on the first actuationelement 908 a such that it divides the first actuation element 908 ainto a first portion 908 a ₁ and a second portion 908 a ₂. Likewise, thesecond target 910 b is positioned on the second actuation element 908 bsuch that it divides the second actuation element 908 b into a firstportion 908 b ₁ and a second portion 908 b ₂. Energy received at thefirst target 910 a can spread into both the first portion 908 a ₁ andthe second portion 908 a ₂ of the first actuation element 908 a, andenergy received at the second target 910 b can spread into both thefirst portion 908 b ₁ and the second portion 908 b ₂ of the secondactuation element 908 b. Without being bound by theory, placing thetargets 910 along the actuation elements 908 is therefore expected tomore quickly and/or efficiently spread energy received at the targets910 into the corresponding actuation elements 908 for driving operationthereof (e.g., by reducing the dissipative loss of heat within theactuation elements 908).

The actuator 901 further includes a first aperture 911 a and a secondaperture 911 b for securing the actuator 901 to a drainage element,plate, or other structure (e.g., the drainage element 750 of the system10, shown in FIG. 7A). For example, the first aperture 911 a can beconfigured to receive a first pin or other anchoring element, and thesecond aperture 911 b can be configured to receive a second pin or otheranchoring element. Accordingly, the actuator 901 is securable to adrainage element or other shunting structure at two locations. In someembodiments, the actuator 901 is configured to be rotatably secured tothe drainage element or other shunting structure at least at the firstaperture 911 a such that the projection 902 can rotate upon actuation ofthe actuation elements 908, as previously described with respect to theactuator 701 of FIGS. 7A-7E.

The actuator 901 can be manufactured and operated in a manner generallysimilar to those described for the actuator 701 and 801. FIG. 9B, forexample, illustrates the actuator 901 in a fabricated or non-tensionedposition, in which the actuator 901 has a first length L₁. The actuator901 can be fabricated from a unitary or contiguous piece of material(e.g., nitinol), as previously described with respect to FIGS. 7A-7E.Once fabricated, the actuator 901 can be manipulated into a different,tensioned configuration before/while being secured to a shunt or otherstructure (e.g., the actuator 901 may be manipulated such that the firstaperture 911 a and the second aperture 911 b align with and engage pinsextending from a drainage element or other shunting structure). FIG. 9Cillustrates the actuator 901 in a tensioned configuration in which theactuator 901 has been stretched or otherwise lengthened relative to thefabricated position such that it has a second length L2 that is greaterthan the first length L₁. In other embodiments, the actuator 901 may becompressed relative to the fabricated configuration to form a tensionedconfiguration in which L2 would be less than L₁. In the tensionedposition shown in FIG. 9C, the first actuation element 908 a and thesecond actuation element 908 b are both lengthened relative to theirpreferred (e.g., fabricated) geometries. Accordingly, as previouslydescribed with respect to FIGS. 7A-7E, the first actuation element 908 aand the second actuation element 908 b can be selectively actuated byapplying energy to the first target 910 a or the second target 910 b,respectively, to rotate the projection 902 to block or unblock a fluidinlet on the shunt structure (not shown). FIG. 9D, for example,illustrates the actuator 901 following actuation of the second actuationelement 908 b. Because the second actuation element 908 b is lengthenedrelative to its preferred (e.g., fabricated) geometry, heating at leasta portion of the second actuation element 908 b above its transitiontemperature induces a material phase change in the second actuationelement 908 b, causing the second actuation element 908 b to contracttoward its preferred (e.g., fabricated) geometry. This causes the distalregion 902 b of the projection 902 to rotate upwardly. This movement canbe reversed by heating at least a portion of the first actuation element908 a above its transition temperature to induce a material phase changetherein, causing the first actuation element 908 a to contract towardits preferred (e.g., fabricated) geometry and rotate the projection 902downwardly.

FIGS. 10A-10D illustrate another actuator 1001 for controlling the flowof fluid in a shunting system and configured in accordance with selectembodiments of the present technology. More specifically, FIG. 10A is anisometric view of the actuator 1001, FIG. 10B is a top view of theactuator 1001 in a fabricated or non-tensioned configuration, FIG. 10Cis a top view of the actuator 1001 in a tensioned configuration, andFIG. 10D is a top view of the actuator 1001 in an actuatedconfiguration. The actuator 1001 is shown in isolation for clarity.However, as one skilled in the art will appreciate, the actuator 1001can be used in systems similar to the system 10 or the system 20described with reference to FIGS. 7A-7E and FIGS. 8A-8C, respectively(e.g., instead of the actuators 701 and 801, respectively). Moreover,the actuator 1001 can operate in a manner generally similar to theactuator 701 (FIGS. 7A-7E), the actuator 801 (FIGS. 8A-8C), and/or theactuator 901 (FIGS. 9A-9D) previously described. Accordingly, thefollowing description places particular focus on features and functionsof the actuator 1001 that are different than those previously described.

Referring first to FIG. 10A, the actuator 1001 includes a projection1002, a first actuation element 1008 a, and a second actuation element1008 b (collectively referred to as the “actuation elements 1008”). Inoperation, the actuation elements 1008 can be selectively andindependently actuated to rotate the projection 1002 to block or unblocka fluid inlet (e.g., the fluid inlet 716 of the system 10, shown in FIG.7A) for controlling the flow of fluid therethrough, as previouslydescribed herein. The actuator 1001 also includes a first target 1010 aand a second target 1010 b (collectively referred to herein as the“targets 1010”) for receiving energy to power the actuators. Similar tothe actuator 901 of FIGS. 9A-9D, the targets 1010 of the actuator 1001are positioned along the respective actuation elements 1008 tofacilitate quicker and/or more efficient heating of the actuationelement 1008 upon application of energy to the respective targets 1010.

The actuator 1001 further includes a first aperture 1011 a, a secondaperture 1011 b, and a third aperture 1011 c for securing the actuator1001 to a drainage element, plate, or other structure (e.g., thedrainage element 750 of the system 10, shown in FIG. 7A). Accordingly,the actuator 1001 is securable to a drainage element or other shuntingstructure at least at three locations. In some embodiments, the actuator1001 is configured to be rotatably secured to the drainage element orother shunting structure at least at the first aperture 1011 a such thatthe projection 1002 can rotate upon actuation of the actuation elements1008, as previously described with respect to the actuator 701 of FIGS.7A-7E. In some embodiments, the actuator 1001 is also configured to berotatably secured to the drainage element or other shunting structure atthe second aperture 1011 b and the third aperture 1011 c, although inother embodiments the actuator 1001 is configured to be fixedly securedto the drainage element at the second aperture 1011 b and/or the thirdaperture 1011 c. Accordingly, the actuator 1001 can have between one andthree rotational degrees of freedom.

The actuator 1001 can be manufactured and operated in a manner generallysimilar to those described previously. FIG. 10B illustrates the actuator1001 in a fabricated or non-tensioned position, in which the actuator1001 has a first length L₁. The actuator 1001 can be fabricated from aunitary or contiguous piece of material (e.g., nitinol), as previouslydescribed with respect to FIGS. 7A-7E. Once fabricated, the actuator1001 can be manipulated into a different, tensioned configurationbefore/while being secured to a shunt or other structure (e.g., theactuator 100 may be manipulated such that the first aperture 1011 a, thesecond aperture 1011 b, and the third aperture 1011 c align with andengage pins extending from a plate or other drainage element). FIG. 10Cillustrates the actuator 1001 in a tensioned configuration in which theactuator 1001 has been stretched or otherwise lengthened relative to thefabricated position such that it has a second length L2 that is greaterthan the first length L₁. In other embodiments, the actuator 1001 may becompressed relative to the fabricated configuration to form a tensionedconfiguration in which L2 would be less than L₁. In the tensionedposition shown in FIG. 10C, the first actuation element 1008 a and thesecond actuation element 1008 b are both lengthened relative to theirpreferred (e.g., fabricated) geometries. Accordingly, as previouslydescribed with respect to FIGS. 7A-7E, the first actuation element 1008a and the second actuation element 1008 b can be selectively actuated byapplying energy to the first target 1010 a or the second target 1010 b,respectively, to rotate the projection 1002 to block or unblock a fluidinlet on the shunt structure (not shown). FIG. 10D, for example,illustrates the actuator 1001 following actuation of the first actuationelement 1008 a. Because the first actuation element 1008 a is lengthenedrelative to its preferred geometry, heating at least a portion of thefirst actuation element 1008 a above its transition temperature inducesa material phase change in the first actuation element 1008 a, causingthe first actuation element 1008 a to contract toward its preferredgeometry. This causes the distal region 1002 b of the projection 1002 torotate downwardly. This movement can be reversed by heating at least aportion of the second actuation element 1008 b above its transitiontemperature to induce a material phase change therein, causing thesecond actuation element 1008 b to contract toward its preferredgeometry and rotate the projection 1002 upwardly.

As shown in FIG. 10D, actuating one of the actuation elements 1008 maycause a first end region 1001 a and a second end region 1001 b of theactuator 1001 to bend or flare inwardly. This can be reduced orprevented by preventing rotation at the second aperture 1011 b and thethird aperture 1011 c (e.g., by preventing rotation about the pins usedto secure the actuator 1001 to a drainage element, plate, or othershunting structure), and/or using one or more restraints similar to thefirst target second restraint 726 a and the second target secondrestraint 726 b shown in FIGS. 7B and 7C. Without being bound by theory,preventing rotation at the first end region 1001 a and the second endregion 1001 b is expected to produce greater displacement of theprojection 1002 and/or increase strain within unconstrained portions ofthe actuator 1001.

FIGS. 11A-11D illustrate another actuator 1101 for controlling the flowof fluid in a shunting system and configured in accordance with selectembodiments of the present technology. More specifically, FIG. 11A is anisometric view of the actuator 1101 in a fabricated or non-tensionedconfiguration, FIG. 11B is a top view of the actuator 1101 in thefabricated or non-tensioned configuration, FIG. 11C is a top view of theactuator 1101 in a tensioned configuration, and FIG. 11D is a top viewof the actuator 1101 in an actuated configuration. The actuator 1101 isshown in isolation for clarity. However, as one skilled in the art willappreciate, the actuator 1101 can be used in systems similar to thesystem 10 or the system 20 described with reference to FIGS. 7A-7E andFIGS. 8A-8C, respectively (e.g., instead of the actuators 701 and 801,respectively). Moreover, the actuator 1101 can operate in a mannergenerally similar to the actuator 701 (FIGS. 7A-7E), the actuator 801(FIGS. 8A-8C), the actuator 901 (FIGS. 9A-9D), and/or the actuator 1001(FIGS. 10A-10D) previously described. Accordingly, the followingdescription places particular focus on features and functions of theactuator 1101 that are different than those previously described.

Unlike the actuators 701, 801, 901, and 1001, the actuator 1101 can besecured to itself to transform the actuator 1101 from the fabricatedconfiguration to the tensioned configuration. For example, referring toFIGS. 11A and 11B, which shows the actuator 1101 in the fabricatedconfiguration, the actuator 1101 includes a first arm 1113 a and asecond arm 1113 b extending generally parallel to the first actuationelement 1108 a and the second actuation element 1108 b, respectively. Afirst appendage 1115 a extends laterally inward from the first arm 1113a toward the second arm 1113 b, and a second appendage 1115 b extendslaterally inward from the second arm 1113 b toward the first arm 1113 a.The actuator 1101 further includes an anchoring element 1111 extendingin a direction generally opposite of the projection 1102. In thefabricated configuration, the anchoring element 1111 resides on the sameside of the first and second appendages 1115 as the projection 1102 andactuation elements 1108. To secure the actuator 1101 in a tensionedconfiguration as shown in FIG. 11C, the anchoring element 1111 can bestretched and positioned on the side of the first and second appendages1115 opposite to the projection 1102 and the actuation element 1108. Asshown, the appendages 1115 interfere with the anchoring element 1111 andprevent the anchoring element 1111 (and thus the actuation elements1108) from returning to the fabricated configuration. This deforms(e.g., lengthens) the actuation elements 1108 relative to theirpreferred (e.g., fabricated) geometries, thereby enabling them to beselectively actuated by heating them above their transitiontemperatures, as previously described. The actuator 1101 therefore doesnot require pins or other fastening elements to secure the actuator 1101in a tensioned configuration. In some embodiments, the anchoring element1111 can be optionally secured to the appendages 1115 followingtensioning of the actuator 1101. The can be done by bonding (e.g.,welding, adhesive, etc.). Although FIGS. 11C and 11D show the anchoringelement 1111 overlapping with the appendages 1115, the anchoringelements 1111 generally would not overlap the appendages 1115.

Once secured in the tensioned configuration, the actuator 1101 canoperate in a generally similar manner as described for the actuator 701.For example, the first actuation element 1108 a and the second actuationelement 1108 b can be selectively actuated by applying energy to thefirst target 1110 a or the second target 1110 b, respectively, to rotatethe projection 1102 to block or unblock a fluid inlet on the shuntstructure (not shown). FIG. 11D, for example, illustrates the actuator1101 following actuation of the first actuation element 1108 a. Becausethe first actuation element 1108 a is lengthened relative to itspreferred geometry, heating at least a portion of the first actuationelement 1108 a above its transition temperature induces a material phasechange in the first actuation element 1108 a, causing the firstactuation element 1108 a to contract toward its preferred geometry. Thiscauses the distal region 1102 b of the projection 1102 to rotatedownwardly. This movement can be reversed by heating at least a portionof the second actuation element 1108 b above its transition temperatureto induce a material phase change therein, causing the second actuationelement 1108 b to contract toward its preferred geometry and rotate theprojection 1102 upwardly.

In some embodiments, the arms 1113 are not constrained by other aspectsof the shunting system (e.g., the system 10 shown in FIG. 7A), andtherefore bow slightly outward during operation of the actuator 1101. Inother embodiments, the arms 1113 can be constrained by one or morefeatures of the shunting system to prevent the arms 1113 from bowingoutward during operation of the actuator 1101. Preventing the arms 1113from bowing outward shifts more energy into the actuation elements 1108,thereby permitting greater displacement of the projection 1102.Therefore, the arms 1113 can be optionally restrained to create a tuningmechanism for adjusting the range of motion of the projection 1102.

FIGS. 12A-12D illustrate yet another actuator 1201 for controlling theflow of fluid in a shunting system and configured in accordance withselect embodiments of the present technology. More specifically, FIG.12A is an isometric view of the actuator 1201 in a fabricated ornon-tensioned configuration, FIG. 12B is a top view of the actuator 1201in the fabricated or non-tensioned configuration, FIG. 12C is a top viewof the actuator 1201 in a tensioned configuration, and FIG. 12D is a topview of the actuator 1201 in an actuated configuration. The actuator1201 is shown in isolation for clarity. However, as one skilled in theart will appreciate, the actuator 1201 can be used in systems similar tothe system 10 or the system 20 described with reference to FIGS. 7A-7Eand FIGS. 8A-8C, respectively (e.g., instead of the actuators 701 and801, respectively). Moreover, the actuator 1101 can operate in a mannergenerally similar to the actuator 701 (FIGS. 7A-7E), the actuator 801(FIGS. 8A-8C), the actuator 901 (FIGS. 9A-9D), the actuator 1001 (FIGS.10A-10D), and/or the actuator 1101 (FIGS. 11A-11D) previously described.Accordingly, the following description places particular focus onfeatures and functions of the actuator 1201 that are different thanthose previously described.

Similar to the actuator 1101, the actuator 1201 can be secured to itselfto transition the actuator 1201 from the fabricated configuration to thetensioned configuration. Referring to FIGS. 12A and 12B, which show theactuator 1201 in a fabricated configuration, the actuator 1201 includesa first arm 1213 a and a second arm 1213 b extending generally parallelto the first actuation element 1208 a and the second actuation element1208 b, respectively. The actuator 1101 further includes an anchoringelement 1111 extending in a direction generally opposite of theprojection 1102. The actuator 1201 further includes a bridge element1215 coupling the first arm 1213 a to the second arm 1213 b andenclosing the anchoring element 1111, the projection 1202, the firstactuation element 1208 a, and the second actuation element 1208 b. Tosecure the actuator 1201 in a tensioned configuration as shown in FIG.12C, the anchor element 1211 can be secured to the bridge 1215, therebydeforming (e.g., lengthening) the first actuation element 1208 a and thesecond actuation element 1208 b relative to their preferred (e.g.,fabricated) geometries. The anchor element 1211 can be secured to thebridge 1215 via a locking mechanism or other suitable adhesiontechniques (e.g. welding, suturing, gluing, taping, etc.). In someembodiments, the bridge 1215 may include a recess configured to receiveand secure the anchor element 1211.

Once secured in the tensioned configuration, the actuator 1201 canoperate in a generally similar manner as described for the actuator 701.For example, the first actuation element 1208 a and the second actuationelement 1208 b can be selectively actuated by applying energy to thefirst target 1210 a or the second target 1210 b, respectively, to rotatethe projection 1202 to block or unblock a fluid inlet on the shuntstructure (not shown). FIG. 12D, for example, illustrates the actuator1201 following actuation of the first actuation element 1208 a. Becausethe first actuation element 1208 a is lengthened relative to itspreferred geometry, heating at least a portion of the first actuationelement 1208 a above its transition temperature induces a material phasechange in the first actuation element 1208 a, causing the firstactuation element 1208 a to contract toward its preferred geometry. Thiscauses the distal region 1202 b of the projection 1202 to rotatedownwardly. This movement can be reversed by heating at least a portionof the second actuation element 1208 b above its transition temperatureto induce a material phase change therein, causing the second actuationelement 1208 b to contract toward its preferred geometry and rotate theprojection 1202 upwardly. As described above with respect to the FIG.11D, the arms 1213 can optionally be restrained when the actuator 1301is positioned within a shunting system (e.g., the system 10) to reduceoutward bowing during operation and/or to tune operation of the actuator1201.

FIGS. 13A-13D illustrate yet another actuator 1301 for controlling theflow of fluid in a shunting system and configured in accordance withselect embodiments of the present technology. More specifically, FIG.13A is an isometric view of the actuator 1301 in a fabricated ornon-tensioned configuration, FIG. 13B is a top view of the actuator 1301in the fabricated or non-tensioned configuration, FIG. 13C is a top viewof the actuator 1301 in a tensioned configuration, and FIG. 13D is a topview of the actuator 1301 in an actuated configuration. The actuator1301 is shown in isolation for clarity. However, as one skilled in theart will appreciate, the actuator 1301 can be used in systems similar tothe system 10 or the system 20 described with reference to FIGS. 7A-7Eand FIGS. 8A-8C, respectively (e.g., instead of the actuators 701 and801, respectively). Moreover, the actuator 1101 can operate in a mannergenerally similar to the actuator 701 (FIGS. 7A-7E), the actuator 801(FIGS. 8A-8C), the actuator 901 (FIGS. 9A-9D), the actuator 1001 (FIGS.10A-10D), the actuator 1101 (FIGS. 11A-11D), and/or the actuator 1201(FIGS. 12A-12D) previously described. Accordingly, the followingdescription places particular focus on features and functions of theactuator 1301 that are different than those previously described.

The actuator 1301 includes a first arm 1313 a and a second arm 1313 bextending generally parallel to the first actuation element 1308 a andthe second actuation element 1308 b, respectively. The actuator 1301also includes an anchoring element 1315 having an aperture 1311extending therethrough. To secure the actuator 1301 to a drainageelement, plate, or other shunting structure (not shown) in a tensionedconfiguration, the anchoring element 1315 can be secured to the drainageelement via one or more pins inserted into the aperture 1311. This caninclude deforming the actuator 1301 relative to its fabricatedconfiguration to occupy a tensioned configuration (shown in FIG. 13C).The actuator 1301 can be retained in its tensioned configuration byvirtue of free end regions 1313 a ₁ and 1313 b ₁ of the first and secondarms 1313 a, 1313 b engaging one or more features on the drainageelement. Once secured in the tensioned configuration, the actuator 1301can operate in a generally similar manner as described for the otheractuators herein (e.g., the actuator 1301 can be actuated to move theprojection 1302, as shown in FIG. 13D).

FIGS. 14A-14E illustrate a flow control assembly 1400 (“the assembly1400”) for controlling the flow of fluid in a shunting system andconfigured in accordance with select embodiments of the presenttechnology. More specifically, FIG. 14A is an isometric view of theassembly 1400, FIG. 14B is an isometric view of a base structure 1420 ofthe assembly 1400 with the other features omitted for clarity, FIG. 14Cis a top down view of the assembly 1400 in a fabricated or non-tensionedconfiguration, FIG. 14D is a top down view of the assembly 1400 in aloaded or tensioned configuration, and FIG. 14E is a top down view ofthe assembly 1400 in the loaded or tensioned configuration after it hasbeen actuated relative to the configuration shown in FIG. 14D.

Referring first to FIG. 14A, the assembly 1400 includes a first actuator1401 a, a second actuator 1401 b, and a base structure 1420. The firstactuator 1401 a and the second actuator 1401 b (referred to collectivelyas “the actuators 1401”) can be coupled to the base structure 1420,which is described in greater detail below with reference to FIG. 14B.In some embodiments, the assembly 1400 can be used in systems similar tothe system 10 or the system 20 described with reference to FIGS. 7A-7Eand FIGS. 8A-8C, respectively (e.g., instead of the actuators 701 and801, respectively). In other embodiments, the assembly 1400 can becoupled to another drainage element or shunting structure for drainingfluid.

The first actuator 1401 a can include a first anchoring region 1404 a ₁and a second anchoring region 1404 a ₂. The first actuator 1401 a can becoupled to the base structure 1420 at the first anchoring region 1404 a₁ and the second anchoring region 1404 a ₂. For example, the firstanchoring region 1404 a ₁ can have a first opening 1406 a ₁ extendingtherethrough that is configured to receive a first anchoring mechanismor pin 1422 a ₁ extending from the base structure 1420. Likewise, thesecond anchoring region 1404 a ₂ can include a second opening 1406 a ₂extending therethrough that is configured to receive a second anchoringmechanism or pin 1422 a ₂ extending from the base structure 1420. Insome embodiments, the first actuator 1401 a may alternatively oradditionally be coupled to the base structure 1420 via other suitableconnection mechanisms, such as gluing, welding, or the like. In someembodiments, the first anchoring region 1404 a ₁ and/or the secondanchoring region 1404 a ₂ is rotatably/pivotably coupled to the basestructure 1420 such that the first anchoring region 1404 a ₁ and/or thesecond anchoring region 1404 a ₂ can rotate about the first pin 1422 a ₁and/or the second pin 1422 a ₂, respectively. In some embodiments, thesecond anchoring region 1404 a ₂ is rotatably coupled to the basestructure 1420 and the first anchoring region 1404 a ₁ is fixedlycoupled to the base structure (e.g., to prevent rotation of the firstanchoring region 1404 a ₁ relative to the base structure 1420).

The first actuator 1401 a further includes a projection 1402 a extendingfrom the second anchoring region 1404 a ₂. The projection 1402 a can beor include a finger, a tongue, a lever, a gating element, a controlelement, or the like. The projection 1402 a can further include anopening or aperture 1403 a extending therethrough. The projection 1402 acan be configured to control the flow of fluid through a first fluidinlet 1424 a (shown in FIG. 3B) on the base structure 1420. For example,as described in greater detail below with reference to FIGS. 14D and14E, the projection 1402 a can be moved between a first (e.g., open)position in which the opening 1403 a at least partially aligns with thefirst fluid inlet 1424 a (permitting fluid to flow through the firstfluid inlet 1424 a) and a second (e.g., closed) position in which theopening 1403 a does not align with the first fluid inlet 1424 a(substantially preventing fluid to flow through the first fluid inlet1424 a).

The first actuator 1401 a further includes a first actuation element1408 a ₁ and a second actuation element 1408 a ₂ (collectively referredto as the actuation elements 1408 a) to induce movement of theprojection 1402. The actuation elements 1408 a can extend between thefirst anchoring region 1404 a ₁ and the second anchoring region 1404 a₂. The actuation elements 1408 a can be composed of a shape memorymaterial (e.g., nitinol), and can be actuated via a shape memory effect,as previously described in detail herein. In operation, the actuationelements 1408 a can be selectively and independently actuated to rotatethe projection 1402 a such that the opening 1403 a at least partiallyaligns with the first fluid inlet 1424 a or such that the opening 1403 adoes not align with the first fluid inlet 1424 a, thereby controllingthe flow of fluid through the first fluid inlet 1424 a.

The second actuator 1401 b can be generally similar to and/or the sameas the first actuator 1401 a, and can be configured to control the flowof fluid through a second fluid inlet 1424 b of the base structure 1420(FIG. 14B). Moreover, although shown has having two actuators 1401, theassembly 1400 can have fewer or more actuators, such as one, three,four, five, six, or more actuators.

Referring next to FIG. 14B, the base structure 1420 can be a generallyflat or plate-like structure having one or more retention features forsecuring the actuators 1401 to the base structure 1420. The retentionfeatures can include the first pin 1422 a ₁ and the second pin 1422 a ₂for securing the first actuator 1401 a to the base structure 1420, aspreviously described. The retention features can also include a thirdpin 1422 b ₁ and a fourth pin 1422 b ₂ for securing the second actuator1401 b to the base structure 1420. Although shown as pins, the basestructure 1420 can include other suitable anchoring or retentionfeatures for securing the actuators 1401 thereto. As described above,the base structure 1420 also includes the first fluid inlet 1424 a andthe second fluid inlet 1424 b. When the assembly 1400 is secured to orpositioned within a drainage element, the first fluid inlet 1424 aand/or the second fluid inlet 1424 b can align with or otherwise be influid communication with one or more channels or lumens that transportfluid entering the drainage element via the first fluid inlet 1424 aand/or the second fluid inlet 1424 b to a desired outflow location.

FIG. 14C illustrates the actuators 1401 coupled to the base structure1420 in a nontensioned or uncoupled configuration in which the firstactuation element 1408 a ₁ of the first actuator 1401 a is not coupledto the first anchoring region 1404 a ₁. As illustrated, the firstactuation element 1408 a ₁ can include a locking feature 1410 a (e.g., aflange, lip, protrusion, key, etc.) configured engage (e.g., releasablyengage) a retention feature 1412 a (e.g., a groove, notch, aperture,etc.) on the first anchoring region 1404 a ₁. In other embodiments, thefirst anchoring region 1404 a ₁ can include the locking feature 1410 a,and the first actuation element 1408 a ₁ can include the retentionfeature 1412 b. In yet other embodiments, the second actuation element1408 a ₂ may include a locking feature and be decoupled from the firstor second anchoring region. In some embodiments, the first actuator 1401a is fabricated in the uncoupled or nontensioned configuration. Forexample, the first actuator 1401 a may be laser cut from a single pieceof material, such that the first actuator 1401 a comprises a unitarystructure.

To transition the first actuator 1401 a from the nontensionedconfiguration shown in FIG. 14C to the tensioned configuration shown inFIG. 14D, the locking feature 1410 a can be positioned within orotherwise interfaced with the retention feature 1412 a. The act ofpositioning the locking feature 1410 a in the retention feature 1412 acan deform at least one of the actuation elements 1408 a relative totheir preferred or fabricated geometry. For example, positioning thelocking feature 1410 a in the retention feature 1412 a can stretch(e.g., tension) the first actuation element 1408 a ₁ relative to itspreferred geometry and/or can stretch (e.g., tension) the secondactuation element 1408 a ₂ relative to its preferred geometry. In someembodiments, both the first actuation element 1408 a ₁ and the secondactuation element 1408 a ₂ are under substantially equal tension when inthe tensioned configuration shown in FIG. 14C. As shown in FIG. 14D, inthe coupled or tensioned configuration, the projection 1402 a blocks thefirst fluid inlet 1424 a (e.g., the opening 1403 a does not align withthe first fluid inlet 1424 a). In use, this prevents or substantiallyprevents fluid from flowing through the first fluid inlet 1424 a. Thesecond actuator 1401 b can be transitioned between the nontensioned andtensioned configurations in the same or similar manner as described forthe first actuator 1401 a.

Because the actuators 1401 are deformed relative to their preferredgeometries in the tensioned configuration, movement of the actuators1401 can be induced via the shape memory effect, as previously describedherein for other shape memory actuators. For example, heating the secondactuation element 1408 a ₂ above its transition temperature can induce aphase transformation therein and cause it to move toward its preferredgeometry. In particular, as shown in FIG. 14E, applying energy to thesecond actuation element 1408 a ₂ causes it to contract toward itspreferred geometry. Because the second actuation element 1408 a ₂ iscoupled to the second anchoring region 1404 a ₂, contraction of thesecond actuation element 1408 a ₂ causes the second anchoring region1404 a ₂ to pivot or otherwise rotate about the second pin 1422 a ₂ asit contracts. This causes the projection 1402 a, which extends from thesecond anchoring region 1404 a ₂, to also rotate relative to the basestructure 1420. In the illustrated embodiment, the projection 1402 arotates in a clockwise direction relative to the base structure 1420upon actuation of the second actuation element 1408 a ₂ such that theopening 1403 a aligns with the first fluid inlet 1424 a. In use, thispermits fluid to flow through the first fluid inlet 1424 a. Theoperation can be reversed (e.g., the first actuator 1401 a can be movedto and/or toward the configuration shown in FIG. 14D) by actuating thefirst actuation element 1408 a ₁. The actuation elements 1408 cantherefore be selectively actuated to permit or prevent fluid fromflowing through the first fluid inlet 1424 a.

Although the projection 1402 a is shown as having an opening 1403 a thataligns with the first fluid inlet 1424 a, in other embodiments theopening 1403 a can be omitted from the projection 1402 a, and theprojection 1402 a can simply move between a first position blocking (orsubstantially blocking) the first fluid inlet 1424 a, and a secondposition unblocking (or substantially unblocking) the first fluid inlet1424 a, as previously described in detail herein. The second actuator1401 b can operate in the same or similar manner as the first actuator1401 a to control the flow of fluid through the second fluid inlet 1424b.

FIGS. 15A-15D illustrate another flow control assembly (“the assembly1500”) for controlling the flow of fluid in a shunting system andconfigured in accordance with select embodiments of the presenttechnology. More specifically, FIG. 15A is an isometric view of theassembly 1500, FIG. 15B is an enlarged top down view of an actuator 1501a of the assembly 1500, FIG. 15C is an isometric view of a variation ofthe assembly 1500, and FIG. 15C is a series of top down viewsillustrating an actuation element 1508 during operation of the assembly1500.

Referring first the FIG. 15A, the assembly 1500 includes a firstactuator 1501 a, a second actuator 1501 b, a third actuator 1501 c, anda base structure 1520. The first actuator 1501 a, the second actuator1501 b, and the third actuator 1501 c (referred to collectively as “theactuators 1501”) can be coupled to the base structure 1520. The basestructure 1520 can be or include a drainage element having a centrallumen 1522 extending therethrough. In some embodiments, the basestructure 1520 is a first drainage element, and the assembly 1500 isconfigured for use with a second drainage element or shunting structurefor draining fluid, such as those described with reference to FIGS.7A-7E and FIGS. 8A-8C (e.g., the lumen 1522 drains to another drainageelement). Regardless, the base structure 1520 can include a plurality offluid inlets (not shown) that permit fluid to flow into the lumen 1522.As previously described herein, the actuators 1501 can control the flowof fluid through the fluid inlets to control the therapy level providedby the assembly 1500. For example, the first actuator 1501 a caninterface with and control the flow of fluid through a first fluidinlet, the second actuator 1501 b can interface with and control theflow of fluid through a second fluid inlet, and the third actuator 1501c can interface with and control the flow of fluid through a third fluidinlet.

Referring next to FIG. 15B, the first actuator 1501 a can include afirst actuation element 1508 a ₁, a second actuation element 1508 a ₂,and a control element 1502 a positioned generally between the firstactuation element 1508 a ₁ and the second actuation element 1508 a ₂.The control element 1502 a is configured to interface with (e.g.,selectively block and unblock) a fluid inlet on the base structure tocontrol the flow of fluid therethrough. The actuation elements 1508 canbe composed at least partially of a shape memory material and may inducemovement of the control element 1502 a via the shape memory effect, aspreviously described herein. In some embodiments, the actuation elements1508 can have a partially wound, nested, S-shape, or other shape(collectively referred to as a “torsional” shape) supporting torsion ina portion of the actuation elements 1508 wherein the amount of strainreflected in the system is captured by the action of twisting (i.e.,torsion) in the structure. In some embodiments, the degree to which theactuation elements 1508 are wound can be greater than or less than thatillustrated in FIG. 15B.

The first actuation element 1508 a ₁ can further include a first targetfeature 1509 a ₁ and the second actuation element 1508 a ₂ can furtherinclude a second target feature 1509 a ₂ (collectively referred to as“the target features 1509 a”). The target features 1509 a can provide avisual target to aim for when using laser energy to actuate the actuator1501 a. The first actuator 1501 a further includes an outer perimeter1514 a generally encircling the first actuation element 1508 a ₁ and thesecond actuation element 1508 a ₂. The perimeter 1514 a can furtherinclude one or more openings 1516 a for securing the first actuator 1501a to the base structure 1520.

The first actuator 1501 a is shown in an uncoupled or nontensionedconfiguration in FIG. 15B. In some embodiments, the first actuator 1501a is fabricated in the uncoupled or nontensioned configuration. Forexample, the first actuator 1501 a may be laser cut from a single pieceof material, such that the first actuator 1501 a comprises a unitarystructure. To transition the first actuator 1501 a from the nontensionedconfiguration to a tensioned configuration (not shown), the actuationelements 1508 can be stretched (e.g., tensioned) and a locking feature1510 a at the distal end portion of the second actuation element 1508 a₂ can be placed within or otherwise secured to a retention feature 1512a on the perimeter 1514 a. This secures (e.g., releasably secures) thefirst actuator 1501 in a tensioned configuration. In particular, in thetensioned configuration, the first actuation element 1508 a ₁ and thesecond actuation element 1508 a ₂ are deformed relative to theirpreferred geometries. Therefore, the actuation elements 1508 a can beselectively activated via application of energy to inducement movementthereof, as previously described. Because the actuation elements 1508 aare coupled to the control element 1502 a, movement of the actuationelements 1508 a can induce a corresponding movement of the controlelement 1502 a.

FIG. 15C illustrates a variation of the assembly 1500, in which theperimeter 1514 a (FIG. 15A) of the actuation assembly is omitted forclarity. In particular, relative to the assembly 1500 shown in FIG. 15A,the control element 1502 a is placed longitudinally inline with thefirst actuation element 1508 a ₁ and the second actuation element 1508 a₂.

FIG. 15D provides a series of schematic illustrations depictingactuation of the first actuation element 1508 a ₁. In particular, FIG.15D illustrates the configuration of the first actuation element 1508 a₁ as it transitions from its tensioned (e.g., stretched) configurationto and/or toward its preferred geometry (e.g., its nontensionedconfiguration). Because the first actuation element 1508 a ₁ has atorsional shape and is stretched relative to its preferred geometry,transitioning the first actuation element 1508 a ₁ to and/or toward itspreferred geometry causes it to decrease in length and rotate or foldabout its torsional center point (which can be at or proximate the firsttarget 15090. This motion can drive movement of the control element 1502a.

The second actuation element 1508 a ₂ can operate in a manner generallysimilar to the first actuation element 1508 a ₁. However, because thecontrol element 1502 a is positioned between the actuation elements1508, actuation of the first actuation element 1508 a ₁ generally movesthe control element 1502 a in a first direction, and actuation of thesecond actuation element 1508 a ₂ generally moves the control element1502 a in a second direction generally opposite the first direction. Thesecond actuator 1501 b and the third actuator 1501 c can be generallysimilar to and/or the same as the first actuator 1501 a. Moreover,although shown has having three actuators 1501, the assembly 1500 canhave fewer or more actuators, such as one, two, four, five, six, or moreactuators.

The present technology further provides methods of manufacturing thesystems and devices described herein. FIG. 16 , for example, is aflowchart of a method 1600 for manufacturing an adjustable intraocularshunting system, such as the systems 700 and 800 described previously.Beginning at step 1602, the method 1600 includes producing (e.g.,fabricating) an actuator composed, at least in part, of a shape memorymaterial or alloy. In some embodiments, the actuator is a single orunitary component composed of the shape memory material. The actuatorcan be produced via a photolithographic process, via a depositionprocess, via cutting or etching a unitary structure from a sheet orsource material, or other suitable techniques. Additional details ofproducing devices such as actuators via the foregoing techniques aredescribed in U.S. Provisional Patent Application No. 63/039,237, thedisclosure of which is incorporated by reference herein in its entirety.The actuator can be any of the actuators described herein, such as thosedescribed with respect to FIGS. 2-15D.

The method 1600 can continue at step 1604 by deforming the actuatorrelative to its fabricated and/or preferred geometry (e.g., to occupy atensioned configuration) and at step 1606 by securing the deformedactuator to a drainage element, plate, or other shunting structure(e.g., the drainage element 750 or drainage element 850). Deforming theactuator relative to its fabricated geometry can include stretching oneor more aspects of the actuator (e.g., the actuation elements 708)relative to their fabricated geometry such that, when the one or moreaspects are triggered to move toward their fabricated geometries (e.g.,via an induced phase transformation, as previously described), the oneor more aspects of the actuator increase in length. Alternatively,deforming the actuator relative to its fabricated geometry can includecompressing one or more aspects of the actuator (e.g., the actuationelements 708) relative to their fabricated geometry such that, when theone or more aspects are triggered to move toward their fabricatedgeometries, the one or more aspects of the actuator decrease in length.In some embodiments, deforming the actuator relative to its preferredgeometry includes securing a first portion of the actuator to a secondportion of the actuator (e.g., for the actuator 1101 of FIGS. 11A-11D,positioning the anchoring element 1111 on the opposite side of the firstand second appendages 1115 a, 1115 b as the projection 1102).

Securing the deformed actuator to the drainage element at step 1606 caninclude securing the actuator to the drainage element in two or morelocations/positions. In some embodiments, the actuator ispivotably/rotatably coupled to the drainage element at least at one ofthe two or more locations/positions such that a portion of the actuatorcan pivot or otherwise rotate relative to the drainage element, aspreviously described. The actuator can be secured to the drainageelement via any suitable mechanisms, such as pins, anchors, adhesives,fasteners, or the like. In some embodiments, securing the deformedactuator to the drainage element at step 1606 includes positioning thetensioned actuator in a chamber or other portion of a shunting elementor drainage element. After the actuator is secured to the drainageelement, the actuator remains at least partially deformed relative toits fabricated geometry so that the actuator can be actuated using itsshape memory properties, as described in detail previously.

In some embodiments, steps 1604 and 1606 can be reversed, such that theactuator is secured to the drainage element or other shunting structureand then deformed. In other embodiments, the act of securing theactuator to the drainage element or other shunting structure causes theactuator to deform, and thus steps 1604 and 1606 are performed atsubstantially the same time.

The present technology further provides methods of treating a patienthaving glaucoma using the intraocular shunting systems described herein.FIG. 17 , for example, is a flowchart of a method 1700 of treating apatient having glaucoma. Beginning at step 1702, the method 1700includes implanting an intraocular shunting system into the patient'seye such that an inflow region of the shunting system (e.g., the firstend portion 750 a of the drainage element 750) is in fluid communicationwith an interior of the eye (e.g., the anterior chamber) and an outflowregion of the shunting system (e.g., the second end portion 750 b of thedrainage element 750) is in fluid communication with a desired outflowlocation, such as a subconjunctival bleb space. Once implanted, theshunting system can fluidly connect the anterior chamber and the desiredoutflow location and permit aqueous to drain from the anterior chamberto the desired outflow location.

After implanting the shunting system, the method 1700 can continue atstep 1704 by heating a shape memory actuation element (e.g., the firstactuation element 708 a or the second actuation element 708 b) to inducea rotational movement of a flow control element (e.g., the projection702) interfacing with one or more inflow ports at the inflow region. Insome embodiments, heating the shape memory actuation element includesheating, via energy applied from an energy source positioned external tothe patient's body, the shape memory actuation element above a materialtransition temperature such that the actuation element changes from afirst material state (e.g., a martensitic state, R-phase, etc.) to asecond material state (e.g., R-phase, austenitic, etc.). The rotationalmovement of the flow control element can change a flow resistancethrough the one or more inflow ports. For example, the rotationalmovement of the flow control element may further block or unblock theone or more inflow ports, which may permit less or more aqueous fromdraining via the implanted system.

In some embodiments, heating the shape memory actuation element inducesa relatively small geometric change in the actuation element. Therelatively small geometric change in the actuation element drives therotational movement of the flow control element. The rotational movementof a distal end of the flow control element can be a relatively largemotion relative to the geometric change in the actuation element. Thiscan be accomplished via an elongated flow control element such as theprojection 702 described previously with respect to FIGS. 7A-7E.

The step 1704 can be repeated as many times as necessary to achieve adesired drainage rate and/or to account for changes in a patient'scondition. Moreover, the step 1702 and the step 1704 do not necessarilyoccur at the same time and/or during the patient's same visit to receivetherapy. Rather, step 1704 can occur days, months, or even years afterthe system is implanted in the patient in step 1702. Accordingly, method1700 enables a healthcare provider to adjust a level of therapy providedby implanted intraocular systems.

As one of skill in the art will appreciate from the disclosure herein,various components of the intraocular shunting systems described abovecan be omitted without deviating from the scope of the presenttechnology. Likewise, additional components not explicitly describedabove may be added to the intraocular shunting systems without deviatingfrom the scope of the present technology. Accordingly, the systemsdescribed herein are not limited to those configurations expresslyidentified, but rather encompasses variations and alterations of thedescribed systems.

CONCLUSION

The above detailed description of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of the technologyas those skilled in the relevant art will recognize. For example, any ofthe features of the intraocular shunts described herein may be combinedwith any of the features of the other intraocular shunts describedherein and vice versa. Moreover, although steps are presented in a givenorder, alternative embodiments may perform steps in a different order.The various embodiments described herein may also be combined to providefurther embodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions associated with intraocularshunts have not been shown or described in detail to avoid unnecessarilyobscuring the description of the embodiments of the technology. Wherethe context permits, singular or plural terms may also include theplural or singular term, respectively.

Unless the context clearly requires otherwise, throughout thedescription and the examples, the words “comprise,” “comprising,” andthe like are to be construed in an inclusive sense, as opposed to anexclusive or exhaustive sense; that is to say, in the sense of“including, but not limited to.” As used herein, the terms “connected,”“coupled,” or any variant thereof, means any connection or coupling,either direct or indirect, between two or more elements; the coupling ofconnection between the elements can be physical, logical, or acombination thereof. Additionally, the words “herein,” “above,” “below,”and words of similar import, when used in this application, shall referto this application as a whole and not to any particular portions ofthis application. Where the context permits, words in the above DetailedDescription using the singular or plural number may also include theplural or singular number respectively. As used herein, the phrase“and/or” as in “A and/or B” refers to A alone, B alone, and A and B.Additionally, the term “comprising” is used throughout to mean includingat least the recited feature(s) such that any greater number of the samefeature and/or additional types of other features are not precluded. Itwill also be appreciated that specific embodiments have been describedherein for purposes of illustration, but that various modifications maybe made without deviating from the technology. Further, while advantagesassociated with some embodiments of the technology have been describedin the context of those embodiments, other embodiments may also exhibitsuch advantages, and not all embodiments need necessarily exhibit suchadvantages to fall within the scope of the technology. Accordingly, thedisclosure and associated technology can encompass other embodiments notexpressly shown or described herein.

1-56. (canceled)
 57. An implantable actuator for selectively controllingthe flow of fluid through an implantable shunting system, the actuatorcomprising: a first actuation element extending between a first endportion and a first deformable shoulder; a second actuation elementextending between a second end portion and a second deformable shoulder;and a moveable element having— a first portion positioned between andconnected to the first deformable shoulder and the second deformableshoulder, and a second portion extending from the first portion.
 58. Theactuator of claim 57 wherein the second portion of the moveable elementextends toward the first end portion of the first actuation element andthe second end portion of the second actuation element.
 59. The actuatorof claim 57 wherein the second portion of the moveable element extendsaway from the first end portion of the first actuation element and thesecond end portion of the second actuation element.
 60. The actuator ofclaim 57 wherein the second portion of the moveable element extendsbetween the first actuation element and the second actuation element.61. The actuator of claim 57 wherein: the first actuation elementextends from the first deformable shoulder toward the first end portionin a first direction, the second actuation element extends from thesecond deformable shoulder toward the second end portion in a seconddirection, and the second portion of the gating element extends from thefirst portion in a third direction, wherein the first direction, thesecond direction, and the third direction are the same.
 62. The actuatorof claim 57 wherein the first deformable shoulder extends generallyorthogonal to an axial length of the first actuation element, andwherein the second deformable shoulder extends generally orthogonal toan axial length of the second actuation element.
 63. The actuator ofclaim 57 wherein the first actuation element and/or the second actuationelement have an at least partial serpentine shape.
 64. The actuator ofclaim 57 wherein the first end portion of the first actuation elementand the second end portion of the second actuation element areconfigured to be fixedly coupled to a substrate, and wherein, when thefirst end portion and the second end portion are fixedly coupled to thesubstrate: the first actuation element, upon actuation, is configured todeform at least one of the first deformable shoulder or the seconddeformable shoulder to rotate the moveable element in a first direction,and the second actuation element, upon actuation, is configured todeform at least one of the first deformable shoulder or the seconddeformable shoulder to rotate the moveable element in a second directiondifferent than the first direction.
 65. The actuator of claim 57 whereinthe first actuation element, the second actuation element, and themoveable element form a single, contiguous component.
 66. The actuatorof claim 57 wherein the first actuation element and the second actuationelement are composed at least in part of a shape memory material.
 67. Animplantable actuator for selectively controlling the flow of fluidthrough an implantable shunting system, the actuator comprising: a firstactuation element extending between a first end portion and a firstdeformable shoulder; a second actuation element extending between asecond end portion and a second deformable shoulder; and a rotatableprojection coupled between the first deformable shoulder and the seconddeformable shoulder.
 68. The actuator of claim 67 wherein: the firstactuation element extends from the first deformable shoulder toward thefirst end portion in a first direction, the second actuation elementextends from the second deformable shoulder toward the second endportion in a second direction, and the rotatable projection extends froma first portion coupled between the first deformable shoulder and thesecond deformable shoulder in a third direction, wherein the firstdirection, the second direction, and the third direction are the same.69. The actuator of claim 67 wherein the first deformable shoulderextends generally orthogonal to an axial length of the first actuationelement, and wherein the second deformable shoulder extends generallyorthogonal to an axial length of the second actuation element.
 70. Theactuator of claim 67 wherein the first actuation element and/or thesecond actuation element have an at least partial serpentine shape. 71.The actuator of claim 67 wherein the first end portion of the firstactuation element and the second end portion of the second actuationelement are configured to be fixedly coupled to a substrate, andwherein, when the first end portion and the second end portion arefixedly coupled to the substrate: the first actuation element, uponactuation, is configured to deform at least one of the first deformableshoulder or the second deformable shoulder to rotate rotatableprojection in a first direction, and the second actuation element, uponactuation, is configured to deform at least one of the first deformableshoulder or the second deformable shoulder to rotate the rotatableprojection in a second direction different than the first direction. 72.The actuator of claim 67 wherein the first actuation element, the secondactuation element, and the rotatable projection form a single,contiguous component.
 73. The actuator of claim 67 wherein the firstactuation element and the second actuation element are composed at leastin part of a shape memory material.
 74. An implantable actuator forselectively controlling the flow of fluid through an implantableshunting system, the actuator comprising: a first actuation elementhaving a first end portion configured to be fixedly coupled to asubstrate and a first curved end portion spaced apart from the first endportion by a length of the first actuation element; a second actuationelement having a second end portion configured to be fixedly coupled tothe substrate and a second curved end portion spaced apart from thesecond end portion by a length of the second actuation element; and arotatable element positioned between and coupled to the first curved endportion and the second curved end portion, wherein the first curved endportion and the second curved end portion are deformable to facilitaterotation of the rotatable element.
 75. The actuator of claim 74 whereinthe rotatable element is a rotatable projection having: a first portioncoupled to the first curved end portion and the second curved endportion, and a second portion extending from the first portion, thesecond portion configured to have a free end moveable relative to thesubstrate when the first end portion and the second end portion arecoupled to the substrate.
 76. The actuator of claim 75 wherein the freeend is positioned between the first actuation element and the secondactuation element.
 77. The actuator of claim 74 wherein the first curvedend portion extends orthogonal to an axial length of the first actuationelement, and wherein the second curved end portion extends orthogonal toan axial length of the second actuation element.
 78. The actuator ofclaim 74 wherein, when the first end portion of the first actuationelement and the second end portion of the second actuation element arefixedly coupled to the substrate: the first actuation element, uponactuation, is configured to deform at least one of the first curved endportion or the second curved end portion to rotate the rotatable elementin a first direction, and the second actuation element, upon actuation,is configured to deform at least one of the first curved end portion orthe second curved end portion to rotate the rotatable element in asecond direction different than the first direction.
 79. The actuator ofclaim 74 wherein the first actuation element, the second actuationelement, and the rotatable element form a single, contiguous component.80. The actuator of claim 74 wherein the first actuation element and thesecond actuation element are composed at least in part of a shape memorymaterial.
 81. The actuator of claim 74 wherein the substrate includes asurface of the implantable shunting system.